Valve prosthesis configured for deployment in annular spacer

ABSTRACT

Embodiments of the present disclosure are directed to prosthetic heart valves and methods of use thereof. In one implementation, a prosthetic heart valve may include an annular spacer having a spacer opening therein and a disc-shaped wall configured to obstruct blood flow. The annular spacer may be configured for engaging with a native heart valve opening, such as the orifice of a mitral valve. The spacer opening may be sized to be smaller than the native heart valve opening. The prosthetic heart valve may also include a central valve section configured for disposal within the spacer opening. The central valve section may be separate from the annular spacer and may include one or more prosthetic valve leaflets.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/691,032, filed Aug. 30, 2017, now pending, which is acontinuation of U.S. patent application Ser. No. 14/689,608, filed Apr.17, 2015, which issued as U.S. Pat. No. 9,763,657 on Sep. 19, 2017,which is a continuation of U.S. patent application Ser. No. 13/811,308,filed Mar. 7, 2013, which issued as U.S. Pat. No. 9,017,399 on Apr. 28,2015, which is a U.S. national stage entry under 35 U.S.C. § 371 ofInternational Application No. PCT/IL2011/000582, filed Jul. 21, 2011,which claims priority and is a continuation-in-part of:

(a) U.S. patent application Ser. No. 12/840,463, filed Jul. 21, 2010;

(b) U.S. patent application Ser. No. 13/033,852, filed Feb. 24, 2011,which is a continuation-in-part of U.S. patent application Ser. No.12/840,463, filed Jul. 21, 2010; and

claims priority from U.S. Provisional Patent Application No. 61/492,449,filed Jun. 2, 2011.

All of the above-referenced applications are incorporated herein byreference.

FIELD OF THE INVENTION

Embodiments of the present disclosure relate in general to valvereplacement. More specifically, embodiments of the present disclosurerelate to prosthetic valves for replacement of an atrioventricularvalve.

BACKGROUND

Dilation of the annulus of the mitral valve prevents the valve leafletsfrom fully coapting when the valve is closed. Regurgitation of bloodfrom the ventricle into the atrium results in increased total strokevolume and decreased cardiac output, and ultimate weakening of theventricle secondary to a volume overload and a pressure overload of theatrium. Dilation of the annulus is sometimes treated by implanting aprosthetic mitral valve at a patient's native mitral valve.

SUMMARY

For some embodiments of the present disclosure, one or more guidemembers (e.g., wires, sutures, or strings) is configured to be anchoredto respective commissures of a native atrioventricular valve of apatient, and each guide member facilitates the advancement therealong ofrespective commissural anchors. The commissural anchors are shaped so asto define a plurality of barbs or prongs which are expandable torestrict proximal movement of the anchors following their deployment.The guide members facilitate advancement of a collapsible prostheticvalve support (e.g., a skirt) which serves as a base for and receives acollapsible prosthetic mitral valve which is subsequently coupled to thesupport. The support includes a proximal annular element, or ring, and adistal cylindrical element. The cylindrical element is configured topush aside and press against the native leaflets of the native valve,and the proximal annular element is shaped so as to define one or moreholes for sliding the valve support along the one or more guide members.The proximal annular element is configured to be positioned along theannulus of the native valve.

The collapsible prosthetic valve is configured for implantation inand/or at least partial replacement (e.g., full replacement) of thenative atrioventricular valve of the patient, such as a native mitralvalve or a native tricuspid valve. The valve support and the prostheticvalve are configured to assume collapsed states for minimally-invasivedelivery to the diseased native valve, such as by percutaneous ortransluminal delivery using one or more catheters. For some embodiments,the valve support and the prosthetic valve are implanted during anopen-heart procedure.

The prosthetic valve support is shaped so as to define a downstreamskirt. The downstream skirt is configured to be placed at native valve,such that the downstream skirt passes through the orifice of the nativevalve and extends toward, and, in some embodiments partially into, aventricle. The downstream skirt in some embodiments additionally pushesaside and presses against the native leaflets of the native valve, whichare left in place during and after implantation of the prosthetic valvesupport and/or the prosthetic valve.

The proximal annular element has upper and lower surfaces. For someembodiments of the present disclosure, one or more, e.g., a pluralityof, tissue anchors are coupled to the lower surface and facilitateanchoring of the proximal annular element to the annulus of the nativevalve. For some embodiments, the one or more anchors include at leastfirst and second commissural anchors that are configured to be implantedat or in the vicinity of the commissures of the native valve.

The cylindrical element of the valve support has first and second endsand a cylindrical body disposed between the first and second ends. Thefirst end of the cylindrical element is coupled to the annular elementwhile the second end defines a free end of the cylindrical element. Forsome embodiments of the present disclosure, the cylindrical element ofthe valve support is invertible such that (1) during a first period, thesecond end and the cylindrical body of the cylindrical element aredisposed above the annular element (e.g., in the atrium of the heart),and (2) during a second period, the second end and the cylindrical bodyof the cylindrical element are disposed below the annular element (e.g.,in the ventricle of the heart).

For some embodiments, techniques are applied to facilitate sealing ofthe interface between the valve support and the native valve, and/or theinterface between the prosthetic valve and the native valve. Forexample, a sealing balloon may be placed on a valve-facing, lower sideof the annular element of the valve support, the sealing balloon beingconfigured to be inflated such that the balloon seals the interfacebetween the valve support and the native valve. Alternatively oradditionally, commissural helices are wrapped around chordae tendineaeof the patient in order to facilitate sealing of the valve commissuresaround the valve support and/or around the valve. Further alternativelyor additionally, the valve commissures are grasped by grasping elementsthat act in order to facilitate sealing of the commissures around thevalve support and/or around the valve. For some embodiments, one or moreof the aforementioned sealing elements facilitates anchoring of theprosthetic valve to the native valve in addition to facilitatingsealing.

For some embodiments, the prosthetic valve includes an expandable frame(e.g., a wire frame), and a sealing material (such as latex) is disposedon the outer surface of the frame so as to form webbing between at leastsome of the struts of the wire frame, and to provide sealing between thewire frame and the native valve.

For some embodiments, an invertible prosthetic valve support is used tosupport a prosthetic valve. In some embodiments, a sealing element isdisposed circumferentially around a surface of the invertible prostheticvalve support that is initially an inner surface of the invertibleprosthetic valve support. The invertible prosthetic valve support isanchored to the native valve, and is subsequently inverted. Subsequentto the inversion of the invertible prosthetic valve support, the sealingelement is disposed on the outer surface of the invertible prostheticvalve support and acts to seal the interface between the outer surfaceand the native valve.

In accordance with some embodiments of the present disclosure, anapparatus may include a prosthetic valve support configured to be placedat an annulus of a native atrioventricular valve of a patient, theprosthetic valve support defining an annular element that defines aninner cross-sectional area thereof; an expandable prosthetic valveconfigured to be placed into a ventricle of the patient, the prostheticvalve including: an expandable frame; and prosthetic valve leafletscoupled to the expandable frame; the expandable frame of the prostheticvalve being configured such that when the frame is in a non-constrainedstate thereof, a cross-sectional area of the frame, along at least agiven portion of a length of the frame, is greater than thecross-sectional area defined by the annular element of the prostheticvalve support, the prosthetic valve thereby being couplable to theprosthetic valve support at any location along the portion, responsivelyto radial forces acted upon the valve support by the expandable frame,by the expandable frame being expanded when the location along theportion is aligned with the annular element of the prosthetic valvesupport.

For some embodiments, the valve support is collapsible for transcatheterdelivery.

For some embodiments, the native atrioventricular valve includes amitral valve, and the prosthetic valve includes three prostheticleaflets.

For some embodiments, the annular element of the valve support isasymmetrically shaped.

For some embodiments, the annular element is shaped to define a hole,and a center of the hole is disposed asymmetrically with respect to anouter perimeter of the annular element.

For some embodiments, the frame includes proximally-facing protrusionsat a distal end thereof, the protrusions being configured to preventproximal migration of the valve into an atrium.

For some embodiments, the protrusions are disposed at an angle from theframe of more than 40 degrees.

For some embodiments, the protrusions are disposed at an angle from theframe of less than 80 degrees.

For some embodiments, a length of each of the protrusions is less than 5mm.

For some embodiments, the frame includes a single proximally-facingprotrusion corresponding to each native valve leaflet of the valve, eachof the protrusions having a width of less than 1 mm.

For some embodiments, the protrusions are disposed in a sinusoidalconfiguration such that the protrusions conform with a saddle shape ofthe patient's native annulus.

For some embodiments, the protrusions are configured to prevent thenative leaflets from interfering with a left ventricular outflow tractof the patient.

For some embodiments, the frame includes first and second sets of one ormore protrusions, each set of protrusions configured to ensnare arespective native leaflet of the native valve of the patient, the firstset of protrusions being disposed within a first circumferential arcwith respect to a longitudinal axis of the prosthetic valve, on a firstside of a distal end of the frame, the second set of protrusions beingdisposed within a second circumferential are with respect to thelongitudinal axis of the prosthetic valve, on a second side of thedistal end of the frame, the first and second sets being disposed so asto provide first and second gaps therebetween at the distal end of theframe, at least one of the gaps having a circumferential arc of at least20 degrees, the apparatus further including one or more valve guidemembers configured to be delivered to one or more commissures of thenative valve, and to guide the valve such that the first and secondcircumferential arcs are aligned with respective leaflets of the nativevalve and such that the first and second gaps are aligned withrespective commissures of the native valve.

For some embodiments, the at least one of the gaps has a circumferentialarc of at least 60 degrees.

For some embodiments, the first circumferential arc defines an angle ofbetween 25 degrees and 90 degrees about the longitudinal axis of theprosthetic valve.

For some embodiments, the second circumferential arc defines an angle ofbetween 25 degrees and 90 degrees about the longitudinal axis of theprosthetic valve.

For some embodiments, the first circumferential arc defines an angle ofbetween 45 degrees and 75 degrees about the longitudinal axis of theprosthetic valve.

For some embodiments, the second circumferential arc defines an angle ofbetween 45 degrees and 75 degrees about the longitudinal axis of theprosthetic valve.

For some embodiments, the expandable frame of the prosthetic valve isconfigured such that when the frame is in a non-constrained statethereof the frame has a maximum diameter of less than 25 mm.

For some embodiments, the expandable frame of the prosthetic valve isconfigured such that when the frame is in a non-constrained statethereof the frame has a maximum diameter of more than 15 mm.

For some embodiments, the expandable frame of the prosthetic valve isconfigured such that when the frame is in a non-constrained statethereof the frame has a maximum diameter of less than 20 mm.

For some embodiments, the expandable frame of the prosthetic valve isconfigured such that when the frame is in a non-constrained statethereof, a cross-sectional area of the frame at a proximal end of theframe is greater than a cross-sectional area of the frame at a distalend of the frame.

For some embodiments, the expandable frame of the prosthetic valve isconfigured such that when the frame is in the non-constrained statethereof the frame defines a frustoconical shape.

For some embodiments, the expandable frame of the prosthetic valve isconfigured such that when the frame is in the non-constrained statethereof the frame defines a trumpet shape.

In accordance with some embodiments of the present disclosure, a methodmay include placing a prosthetic valve support at an annulus of a nativeatrioventricular valve of a patient, the prosthetic valve supportdefining an annular element that defines an inner cross-sectional areathereof; placing into a ventricle of the patient, an expandableprosthetic valve, the prosthetic valve including an expandable frame,and prosthetic valve leaflets coupled to the expandable frame, theexpandable frame of the prosthetic valve being configured such that whenthe frame is in a non-constrained state thereof, a cross-sectional areaof the frame, along at least a given portion of a length of the frame,is greater than the cross-sectional area defined by the annular elementof the prosthetic valve support; determining a location anywhere alongthe portion at which to couple the expandable valve the prosthetic valvesupport; and in response thereto, aligning the location along theportion of the expandable frame with the annular element of theprosthetic valve support; and coupling the expandable valve to theprosthetic valve support at the location, responsively to radial forcesacted upon the valve support by the expandable frame, by facilitatingexpansion of the expandable frame, when the location along the portionis aligned with the annular element of the prosthetic valve support.

For some embodiments, placing the valve support at the annulus includestranscatheterally placing the valve support at the annulus in acollapsed state.

For some embodiments, the native atrioventricular valve includes amitral valve, and placing the prosthetic valve into the ventricleincludes placing into the ventricle a prosthetic valve that includesthree prosthetic leaflets.

For some embodiments, placing the prosthetic valve support at theannulus includes placing an asymmetrically-shaped prosthetic valvesupport at the annulus.

For some embodiments, placing the prosthetic valve support at theannulus includes placing at the annulus an annular element that isshaped to define a hole, a center of the hole being disposedasymmetrically with respect to an outer perimeter of the annularelement, the annular element being placed such that a center of the holeis disposed asymmetrically with respect to the annulus.

For some embodiments, the frame includes proximally-facing protrusionsat a distal end thereof, the protrusions being configured to preventproximal migration of the valve into an atrium, and coupling theexpandable valve to the prosthetic valve support includes preventingproximal migration of the valve by coupling the valve to the valvesupport such that the leaflets are disposed at least partially betweenthe protrusions and the valve support.

For some embodiments, coupling the expandable valve to the prostheticvalve support includes preventing the native leaflets from interferingwith a left ventricular outflow tract of the patient.

For some embodiments, coupling the expandable valve to the prostheticvalve support includes allowing movement of the leaflets with respect tothe frame while preventing the proximal migration of the valve.

For some embodiments, the frame includes first and second sets of one ormore protrusions, each set of protrusions configured to ensnare arespective native leaflet of the native valve of the patient, the firstset of protrusions being disposed within a first circumferential arcwith respect to a longitudinal axis of the prosthetic valve, on a firstside of a distal end of the frame, the second set of protrusions beingdisposed within a second circumferential arc with respect to thelongitudinal axis of the prosthetic valve, on a second side of thedistal end of the frame, the first and second sets being disposed so asto provide first and second gaps therebetween at the distal end of theframe, at least one of the gaps having a circumferential arc of at least20 degrees, the method further including guiding the valve such that thefirst and second circumferential arcs are aligned with respectiveleaflets of the native valve and such that the first and second gaps arealigned with respective commissures of the native valve.

For some embodiments, facilitating expansion of the frame includesfacilitating expansion of the frame to a maximum diameter of less than25 mm.

For some embodiments, facilitating expansion of the frame includesfacilitating expansion of the frame to a maximum diameter of more than15 mm.

For some embodiments, facilitating expansion of the frame includesfacilitating expansion of the frame to a maximum diameter of less than20 mm.

For some embodiments, facilitating expansion of the frame includesfacilitating expansion of the frame such that a cross-sectional area ofthe frame at a proximal end of the frame is greater than across-sectional area of the frame at a distal end of the frame.

For some embodiments, facilitating expansion of the frame includesfacilitating expansion of the frame such that the frame defines afrustoconical shape.

For some embodiments, facilitating expansion of the frame includesfacilitating expansion of the frame such that the frame defines atrumpet shape.

In accordance with some embodiments of the present disclosure, a methodmay include determining an indication of an area defined by an annulusof a native atrioventricular valve of a patient; selecting a prostheticvalve support by determining that the prosthetic valve support definesan annular element that defines an inner cross-sectional area that isless than the area defined by the annulus; placing the prosthetic valvesupport at the annulus of the native atrioventricular valve; placinginto a ventricle of the patient, an expandable prosthetic valve, theprosthetic valve including an expandable frame, and prosthetic valveleaflets coupled to the expandable frame; coupling the expandable valveto the prosthetic valve support at the location, responsively to radialforces acted upon the valve support by the expandable frame, byfacilitating expansion of the expandable frame, a cross-sectional areadefined by the expandable frame of the prosthetic valve being limited bythe cross-sectional area defined by the annular element of theprosthetic valve support, such as to facilitate sealing of the nativevalve with respect to the prosthetic valve by facilitating closing ofleaflets of the native valve around the prosthetic valve, upondeployment of the prosthetic valve.

For some embodiments, facilitating closing of leaflets of the nativevalve around the prosthetic valve includes facilitating sealing of thenative valve at commissures of the native valve.

For some embodiments, facilitating closing of leaflets of the nativevalve around the prosthetic valve includes facilitating closing of theleaflets of the native valve around an outer surface of the expandableframe.

For some embodiments, placing the valve support at the annulus includestranscatheterally placing the valve support at the annulus in acollapsed state.

For some embodiments, the native atrioventricular valve includes amitral valve, and placing the prosthetic valve into the ventricleincludes placing into the ventricle a prosthetic valve that includesthree prosthetic leaflets.

For some embodiments, placing the prosthetic valve support at theannulus includes placing an asymmetrically-shaped prosthetic valvesupport at the annulus.

For some embodiments, placing the prosthetic valve support at theannulus includes placing at the annulus an annular element that isshaped to define a hole, a center of the hole being disposedasymmetrically with respect to an outer perimeter of the annularelement, the annular element being placed such that a center of the holeis disposed asymmetrically with respect to the annulus.

For some embodiments, the frame includes proximally-facing protrusionsat a distal end thereof, the protrusions being configured to preventproximal migration of the valve into an atrium, and coupling theexpandable valve to the prosthetic valve support includes preventingproximal migration of the valve by coupling the valve to the valvesupport such that the leaflets are disposed at least partially betweenthe protrusions and the valve support.

For some embodiments, coupling the expandable valve to the prostheticvalve support includes preventing the native leaflets from interferingwith a left ventricular outflow tract of the patient.

For some embodiments, coupling the expandable valve to the prostheticvalve support includes allowing movement of the leaflets with respect tothe frame while preventing proximal migration of the valve.

For some embodiments, the frame includes first and second sets of one ormore protrusions, each set of protrusions configured to ensnare arespective native leaflet of the native valve of the patient, the firstset of protrusions being disposed within a first circumferential arcwith respect to a longitudinal axis of the prosthetic valve, on a firstside of a distal end of the frame, the second set of protrusions beingdisposed within a second circumferential arc with respect to thelongitudinal axis of the prosthetic valve, on a second side of thedistal end of the frame, the first and second sets being disposed so asto provide first and second gaps therebetween at the distal end of theframe, at least one of the gaps having a circumferential arc of at least20 degrees, the method further including guiding the valve such that thefirst and second circumferential arcs are aligned with respectiveleaflets of the native valve and such that the first and second gaps arealigned with respective commissures of the native valve.

For some embodiments, facilitating expansion of the frame includesfacilitating expansion of the frame to a maximum diameter of less than25 mm.

For some embodiments, facilitating expansion of the frame includesfacilitating expansion of the frame to a maximum diameter of more than15 mm.

For some embodiments, facilitating expansion of the frame includesfacilitating expansion of the frame to a maximum diameter of less than20 mm.

For some embodiments, facilitating expansion of the frame includesfacilitating expansion of the frame such that a cross-sectional area ofthe frame at a proximal end of the frame is greater than across-sectional area of the frame at a distal end of the frame.

For some embodiments, facilitating expansion of the frame includesfacilitating expansion of the frame such that the frame defines afrustoconical shape.

For some embodiments, facilitating expansion of the frame includesfacilitating expansion of the frame such that the frame defines atrumpet shape.

In accordance with some embodiments of the present disclosure, a methodmay include placing a prosthetic valve support at an annulus of a nativeatrioventricular valve of a patient; placing a prosthetic valve into aventricle of the patient, the prosthetic valve including protrusions ata distal end thereof; ensnaring one or more native leaflets of thenative valve of the patient with the protrusions; and coupling theprosthetic valve to the native valve, by sandwiching native leaflets ofthe native valve between the protrusions and the valve support, bypulling the prosthetic valve proximally with respect to the valvesupport, and while the native leaflets are sandwiched between theprotrusions and the valve support, coupling the prosthetic valve to thevalve support, by facilitating radial expansion of the prosthetic valvesuch that the prosthetic valve is held in place with respect to thevalve support responsively to radial forces acted upon the valve supportby the prosthetic valve.

In accordance with some embodiments of the present disclosure, a methodmay include determining an indication of an area defined by an annulusof a native atrioventricular valve of a patient: selecting a prostheticvalve to be placed in the native valve by determining that the valvedefines a cross-sectional area that is less than 90% of the area definedby the annulus: and deploying the prosthetic valve at the native valve,the selecting of the prosthetic valve facilitating sealing of the nativevalve with respect to the prosthetic valve by facilitating closing ofleaflets of the native valve around the prosthetic valve, upondeployment of the prosthetic valve.

For some embodiments, selecting the prosthetic valve includes selectinga prosthetic valve having a material disposed on an outer surfacethereof.

For some embodiments, selecting the prosthetic valve includes selectinga prosthetic valve having a material that prevents tissue growthdisposed on an outer surface thereof.

For some embodiments, selecting the prosthetic valve includes selectinga prosthetic valve having a material that promotes tissue growthdisposed on an outer surface thereof.

For some embodiments, selecting the prosthetic valve to be placed in thenative valve includes determining that the valve defines across-sectional area that is less than 80% of the area defined by theannulus.

For some embodiments, selecting the prosthetic valve to be placed in thenative valve includes determining that the valve defines across-sectional area that is less than 60% of the area defined by theannulus.

In accordance with some embodiments of the present disclosure, anapparatus may include one or more valve support guide members configuredto be delivered to one or more commissures of a native atrioventricularvalve of a patient; one or more valve support anchors configured to beanchored to the one or more commissures of the native valve; aprosthetic valve support advanceable toward the native valve along theone or more valve support guide members and anchored to the native valveat at least the one or more commissures; and a prosthetic valveconfigured to be coupled to the valve support.

For some embodiments, the valve support is collapsible for transcatheterdelivery and expandable to contact the native atrioventricular valve.

For some embodiments, the one or more valve support anchors areconfigured to be anchored to the one or more commissures fromventricular surfaces thereof.

For some embodiments, the one or more valve support guide membersincludes one valve support guide member that is looped through first andsecond commissures of the atrioventricular valve in a manner in which alooped portion of the valve support guide member is disposed in aventricle of the patient and first and second free ends of the valvesupport guide member are accessible from a site outside a body of thepatient.

For some embodiments, the one or more valve support anchors includesfirst and second tissue anchors, the first and second tissue anchorsbeing configured to be anchored to respective first and secondcommissures of the atrioventricular valve of the patient.

For some embodiments, the one or more valve support anchors each includeone or more radially-expandable prongs, and the one or more prongs aredisposed within a sheath in a compressed state prior to the anchoring,and exposed from within the sheath in order to expand and facilitateanchoring of the valve support anchor to the respective commissures.

For some embodiments, the prosthetic valve includes two or moreprosthetic leaflets.

For some embodiments, the native atrioventricular valve includes amitral valve, and the prosthetic valve includes three prostheticleaflets.

For some embodiments, the valve support guide members are removable fromthe patient following the anchoring of the prosthetic valve support atthe atrioventricular valve.

For some embodiments, the valve support is shaped so as to define adistal portion which is configured to push aside, at least in part,native leaflets of the valve of the patient.

For some embodiments, the one or more valve support anchors areadvanceable along the one or more valve support guide members.

For some embodiments, the valve support is shaped so as to define one ormore holes, the one or more holes being configured to facilitateslidable passage therethrough of a respective one of the one or morevalve support guide members.

For some embodiments, the prosthetic valve is shaped so as to define oneor more snares configured to ensnare one or more native leaflets of thenative valve of the patient.

For some embodiments, the one or more valve support anchors includes oneor more ventricular anchors, and the apparatus further includes one ormore atrial anchors, each atrial anchor being configured to be advancedtoward an atrial surface of the valve support and anchor in place thevalve support in a vicinity of a respective one of the ventricularanchors.

For some embodiments, the apparatus includes one or more deliverylumens, and: each one of the one or more valve support anchors isremovably coupled to a distal end of a respective delivery lumen, thedelivery lumen is configured to facilitate advancement of the one ormore anchors along the one or more guide members, and the delivery lumenis decoupled from the anchor following the anchoring of the anchor tothe one or more commissures.

For some embodiments, the one or more valve support guide members areremovable from the body of the patient following the advancement of theone or more anchors along the one or more guide members.

For some embodiments, the valve support is shaped so as to define one ormore holes, the one or more holes are configured to facilitate slidablepassage therethrough of a respective one of the one or more deliverylumens, and the one or more delivery lumens are decoupleable from therespective valve support anchor following the anchoring of the valvesupport to at least the one or more commissures.

For some embodiments, the one or more delivery lumens are removable fromthe body of the patient following the anchoring of the valve support toat least the one or more commissures.

For some embodiments, the valve support includes an annular element anda generally cylindrical element coupled to the annular element, thegenerally cylindrical element being configured to push aside nativeleaflets of the native valve, the cylindrical element has first andsecond ends and a cylindrical body that is disposed between the firstand second ends.

For some embodiments, the apparatus includes one or more annular elementtissue anchors, the annular element has an upper surface and a lowersurface, and the lower surface is coupled to the one or more annularelement tissue anchors, the one or more annular element tissue anchorsbeing configured to puncture tissue of a native annulus of the nativevalve of the patient.

For some embodiments, one or more annular element tissue anchorsincludes a plurality of annular element tissue anchors positioned aroundthe lower surface of the annular element.

For some embodiments, the one or more annular element tissue anchorsincludes a first commissural anchor configured to puncture tissue of thenative valve at a first commissure thereof, and a second commissuralanchor configured to puncture tissue of the native valve at a secondcommissure thereof.

For some embodiments, each anchor of the one or more annular elementtissue anchors includes a distal pointed tip and one or moreradially-expandable prongs, the prongs being configured to expand andfacilitate anchoring of the anchor and restrict proximal motion of theannular element tissue anchor.

For some embodiments, the apparatus includes one or more prostheticvalve guide members reversibly couplable to the cylindrical element in avicinity of the second end of the cylindrical element, the prostheticvalve guide members being configured to facilitate advancement of theprosthetic valve therealong and toward the valve support.

For some embodiments, the first end of the cylindrical element iscoupled to the annular element, during a first period, the second end ofthe cylindrical element is disposed above the annular element in amanner in which the body of the cylindrical element is disposed abovethe annular element, and the cylindrical element is invertible in amanner in which, during a second period, the second end of thecylindrical element is disposed below the annular element and the bodyof the cylindrical element is disposed below the annular element.

For some embodiments, during the first period, the second end of thecylindrical element is disposed in an atrium of a heart of the patientand the annular element is positioned along an annulus of the nativevalve, the prosthetic valve is advanceable along the one or moreprosthetic valve guide members into a ventricle of the heart of thepatient, and in response to advancement of the prosthetic valve into theventricle, the one or more prosthetic valve guide members are pulledinto the ventricle and pull the second end and the body of thecylindrical element into the ventricle to invert the cylindricalelement.

In accordance with some embodiments of the present disclosure, a methodmay include advancing one or more valve support guide members toward oneor more commissures of a native atrioventricular valve of a patient;advancing along the one or more valve support guide members one or morevalve support tissue anchors toward the one or more commissures;anchoring the one or more valve support tissue anchors to the one ormore commissures; anchoring a prosthetic valve support at the nativeatrioventricular valve by anchoring the prosthetic valve support at atleast the one or more commissures; and coupling a prosthetic valve tothe prosthetic valve support.

For some embodiments, the method includes removing the one or more valvesupport guide members following the anchoring of the prosthetic valvesupport at the native atrioventricular valve.

For some embodiments, advancing the one or more valve support guidemembers toward the one or more commissures includes advancing one guidemember and looping the one guide member through first and secondcommissures of the native atrioventricular valve in a manner in which alooped portion of the guide member is disposed in a ventricle of thepatient and first and second free ends of the guide member areaccessible from a site outside a body of the patient.

For some embodiments, anchoring the one or more valve support anchorsincludes anchoring the one or more valve support anchors to ventricularsurface of the respective commissures of the native valve.

For some embodiments, anchoring the one or more valve support anchorsincludes anchoring first and second tissue anchors to respective firstand second commissures of the native valve.

For some embodiments, advancing along the one or more valve supportguide members the one or more valve support tissue anchors includesadvancing the one or more valve support tissue anchors within a sheath,and anchoring the one or more valve support tissue anchors includesexposing the one or more valve support anchors from within the sheathand facilitating radial expansion of one or more radially-expandableprongs of the one or more anchors.

For some embodiments, coupling the prosthetic valve to the prostheticvalve support includes coupling a prosthetic valve having two or moreleaflets.

For some embodiments, the native atrioventricular valve includes amitral valve of the patient, and coupling the prosthetic valve to theprosthetic valve support includes coupling a prosthetic valve havingthree leaflets.

For some embodiments, anchoring the prosthetic valve support includespushing aside, at least in part, native leaflets of the valve of thepatient by at least a portion of the support.

For some embodiments, the prosthetic valve support is coupled to one ormore annulus tissue anchors, and anchoring the prosthetic valve supportincludes pushing the one or more annulus tissue anchors into tissue ofan annulus of the native valve.

For some embodiments, coupling the prosthetic valve to the prostheticvalve support includes ensnaring one or more native leaflets of thenative valve of the patient by a portion of the prosthetic valve.

For some embodiments, the one or more valve support anchors includes oneor more ventricular anchors, and the method further includes advancingone or more atrial anchors to an atrial surface of the valve support,and anchoring in place the valve support in a vicinity of a respectiveone of the ventricular anchors.

For some embodiments, the method includes advancing the valve supportalong the one or more valve support guide members prior to the anchoringof the valve support.

For some embodiments, the valve support is shaped so as to define one ormore holes, and advancing the valve support along the one or more valvesupport guide members includes threading the one or more valve supportguide members through the one or more holes of the valve support andsliding the valve support along the one or more guide members.

For some embodiments, the method includes removing the one or more valvesupport guide members from a body of the patient following the anchoringof the valve support.

For some embodiments, the valve support includes: an annular element,and a generally cylindrical element having first and second ends and acylindrical body that is disposed between the first and second ends, thefirst end being coupled to the annular element; and anchoring of thevalve support, including anchoring the valve support in a manner inwhich: the annular element is positioned along an annulus of the nativevalve, the second end of the cylindrical element is disposed above theannular element in an atrium of a heart of the patient, and the body ofthe cylindrical element is disposed above the annular element.

For some embodiments, the method includes, following the anchoring,inverting the cylindrical element to pull the second end of thecylindrical element below the annular element and into a ventricle ofthe heart, in a manner in which the body of the cylindrical element isdisposed below the annular element and pushes aside one or more nativeleaflets of the valve of the patient.

For some embodiments, inverting the cylindrical element includesadvancing the prosthetic valve along one or more prosthetic valve guidemembers reversibly coupled to the cylindrical element in a vicinity ofthe second end thereof, advancing the prosthetic valve includesadvancing the prosthetic valve into the ventricle to pull the prostheticvalve guide members and the second end of the cylindrical element intothe ventricle, and the method further includes following the advancingof the prosthetic valve into the ventricle, pulling proximally theprosthetic valve such that a proximal portion of the valve contacts thevalve support.

For some embodiments, pulling the prosthetic valve proximally includesensnaring the one or more leaflets of the valve by a portion of theprosthetic valve.

For some embodiments, advancing the one or more valve support anchorsincludes: providing a respective delivery lumen coupled at a distal endthereof to each one of the one or more anchors, advancing each deliverylumen along a respective one of the one or more valve support guidemembers, facilitating anchoring of each one of the one or more anchorsto the one or more commissures by the respective delivery lumen, anddecoupling the delivery lumen from each one of the one or more valvesupport anchors following the anchoring of the one or more valve supportanchors.

For some embodiments, the method includes removing the one or more valvesupport guide members from a body of the patient following the anchoringof each one of the one or more valve support anchors to the one or morecommissures.

For some embodiments, the method includes advancing the prosthetic valvesupport along the one or more delivery lumens prior to the anchoring thesupport at the native atrioventricular valve.

For some embodiments, the valve support is shaped so as to define one ormore holes, and advancing the valve support along the one or moredelivery lumens includes threading the one or more delivery lumensthrough the one or more holes of the valve support and sliding the valvesupport along the one or more delivery lumens.

For some embodiments, the method includes removing the one or moredelivery lumens from a body of the patient following the anchoring thesupport at the atrioventricular valve.

In accordance with some embodiments of the present disclosure, anapparatus may include a valve support for receiving a prosthetic valve,the valve support including: an annular element configured to bepositioned along a native annulus of a native atrioventricular valve ofa patient; and a flexible generally cylindrical element configured to bepositioned in the native atrioventricular valve of the patient and topush aside native leaflets of the native valve, the cylindrical elementhaving first and second ends and a cylindrical body that is disposedbetween the first and second ends, and: the first end of the cylindricalelement is coupled to the annular element, during a first period, thesecond end of the cylindrical element is disposed above the annularelement in a manner in which the body of the cylindrical element isdisposed above the annular element, and the cylindrical element isinvertible in a manner in which, during a second period, the second endof the cylindrical element is disposed below the annular element and thebody of the cylindrical element is disposed below the annular element.

For some embodiments, the cylindrical element includes a flexiblewireframe covered by a fabric.

For some embodiments, the valve support is collapsible for transcatheterdelivery and expandable to contact the native atrioventricular valve.

For some embodiments, the annular element has an upper surface and alower surface, the lower surface is coupled to one or more annularelement tissue anchors configured to puncture tissue of the nativeannulus of the patient.

For some embodiments, the one or more annular element tissue anchorsincludes a plurality of annular element tissue anchors positioned aroundthe lower surface of the annular element.

For some embodiments, the one or more annular element tissue anchorsincludes a first commissural annular element tissue anchor configured topuncture tissue of the native valve at a first commissure thereof, and asecond commissural annular element tissue anchor configured to puncturetissue of the native valve at a second commissure thereof.

For some embodiments, each anchor of the one or more annular elementtissue anchors includes a distal pointed tip and one or moreradially-expandable prongs, the prongs being configured to expand andfacilitate anchoring of the anchor and restrict proximal motion of theannular element tissue anchor.

For some embodiments, the apparatus includes one or more valve supportguide members configured to be delivered to one or more commissures ofthe native atrioventricular valve of the patient, the one or more valvesupport guide members are configured to facilitate advancement of thevalve support toward the native valve.

For some embodiments, the valve support is shaped so as to define one ormore holes, the one or more holes configured to facilitate slidablepassage therethrough of a respective one of the one or more valvesupport guide members.

For some embodiments, the one or more valve support guide membersincludes one valve support guide member that is looped through first andsecond commissures of the atrioventricular valve in a manner in which alooped portion of the valve support guide member is disposed in aventricle of the patient and first and second free ends of the valvesupport guide member are accessible from a site outside a body of thepatient.

For some embodiments, the apparatus includes one or more valve supporttissue anchors configured to be advanceable along the one or more valvesupport guide members and anchored to the one or more commissures of thevalve.

For some embodiments, the one or more valve support anchors includes oneor more ventricular anchors, and the apparatus further includes one ormore atrial anchors, each atrial anchor being configured to be advancedtoward an atrial surface of the valve support and anchor in place thevalve support in a vicinity of a respective one of the ventricularanchors.

For some embodiments, the valve support guide members are removable fromthe patient following the anchoring of the valve support at theatrioventricular valve.

For some embodiments, the one or more valve support anchors areconfigured to be anchored to the one or more commissures fromventricular surfaces thereof prior to advancement of the valve support.

For some embodiments, the one or more valve support tissue anchorsincludes first and second valve support tissue anchors, the first andsecond valve support tissue anchors being configured to be anchored torespective first and second commissures of the atrioventricular valve ofthe patient.

For some embodiments, the one or more valve support tissue anchors eachinclude one or more radially-expandable prongs, and the one or moreprongs are disposed within a sheath in a compressed state prior to theanchoring and exposed from within the sheath in order to expand andfacilitate anchoring of the anchor to the respective commissures.

For some embodiments, the apparatus includes one or more prostheticvalve guide members reversibly couplable to the cylindrical element in avicinity of the second end of the cylindrical element, the prostheticvalve guide members being configured to facilitate advancement of theprosthetic valve therealong and toward the valve support.

For some embodiments, the apparatus includes the prosthetic valve, andthe prosthetic valve is couplable to the valve support.

For some embodiments, during the first period, the second end of thecylindrical element is disposed in an atrium of a heart of the patientand the annular element is positioned along an annulus of the nativevalve, the prosthetic valve is advanceable along the one or moreprosthetic valve guide members into a ventricle of the heart of thepatient, and in response to advancement of the prosthetic valve into theventricle, the one or more prosthetic valve guide members are pulledinto the ventricle and pull the second end of the cylindrical elementinto the ventricle to invert the cylindrical element.

For some embodiments, the prosthetic valve is collapsible fortranscatheter delivery and expandable when exposed from within adelivery catheter.

For some embodiments, the prosthetic valve includes two or moreprosthetic leaflets.

For some embodiments, the native atrioventricular valve includes amitral valve, and the prosthetic valve includes three prostheticleaflets.

For some embodiments, the prosthetic valve guide members are removablefrom the patient following the anchoring of the prosthetic valve at theatrioventricular valve.

For some embodiments, the prosthetic valve is shaped so as to define oneor more snares configured to ensnare one or more native leaflets of thenative valve of the patient.

In accordance with some embodiments of the present disclosure, a methodmay include advancing toward a native atrioventricular valve of a heartof a patient, a valve support including: an annular element, and agenerally cylindrical element having first and second ends and acylindrical body that is disposed between the first and second ends, thefirst end being coupled to the annular element; anchoring the annularelement to an annulus of the native atrioventricular valve, followingthe anchoring, the second end of the cylindrical element is disposedabove the annular element in an atrium of the heart, in a manner inwhich the body of the cylindrical element is disposed above the annularelement; and following the anchoring, inverting the cylindrical elementto pull the second end of the cylindrical element below the annularelement and into a ventricle of the heart, in a manner in which the bodyof the cylindrical element is disposed below the annular element andpushes aside one or more native leaflets of the valve of the patient.

For some embodiments, anchoring the annular element to the annulus ofthe native atrioventricular valve includes: advancing one or more valvesupport anchors that are distinct from the valve support toward one ormore commissures of the heart, and anchoring the annular element to theannulus using the one or more positioning anchors.

For some embodiments, the annular element is coupled to one or moreannular element tissue anchors, and anchoring the annular elementincludes pushing the one or more annular element tissue anchors intotissue of the annulus.

For some embodiments, inverting the cylindrical element includesadvancing a prosthetic valve along one or more valve guide membersreversibly coupled to the cylindrical element in a vicinity of thesecond end thereof, advancing the prosthetic valve includes advancingthe prosthetic valve into the ventricle to pull the guide members andthe second end of the cylindrical element into the ventricle, and themethod further includes following the advancing of the prosthetic valveinto the ventricle, pulling proximally the prosthetic valve such that aproximal portion of the valve contacts the valve support.

For some embodiments, pulling the prosthetic valve proximally includesensnaring the one or more leaflets of the valve by a portion of theprosthetic valve.

In accordance with some embodiments of the present disclosure, anapparatus may include a valve support for receiving a prosthetic valve,the valve support including: an annular element configured to bepositioned along a native annulus of a native atrioventricular valve ofa patient, the annular element having upper and lower surfaces; and oneor more annular element tissue anchors coupled to the lower surface ofthe annular element, the one or more annular element tissue anchorsbeing configured to puncture tissue of the native annulus of thepatient.

For some embodiments, the valve support is collapsible for transcatheterdelivery and expandable to contact the native atrioventricular valve.

For some embodiments, the one or more annular element tissue anchorsincludes a plurality of annular element tissue anchors positioned aroundthe lower surface of the annular element.

For some embodiments, the one or more annular element tissue anchorsincludes a first commissural annular element tissue anchor configured topuncture tissue of the native valve at a first commissure thereof, and asecond commissural annular element tissue anchor configured to puncturetissue of the native valve at a second commissure thereof.

For some embodiments, each anchor of the one or more annular elementtissue anchors includes a distal pointed tip and one or moreradially-expandable prongs, the prongs being configured to expand andfacilitate anchoring of the anchor and restrict proximal motion of theanchor.

For some embodiments, the apparatus includes one or more valve supportguide members configured to be delivered to one or more commissures ofthe native atrioventricular valve of the patient, the one or more valvesupport guide members are configured to facilitate advancement of thevalve support toward the native valve.

For some embodiments, the valve support is shaped so as to define one ormore holes, the one or more holes configured to facilitate slidablepassage therethrough of a respective one of the one or more valvesupport guide members.

For some embodiments, the one or more valve support guide membersincludes one valve support guide member that is looped through first andsecond commissures of the atrioventricular valve in a manner in which alooped portion of the valve support guide member is disposed in aventricle of the patient and first and second free ends of the valvesupport guide member are accessible from a site outside a body of thepatient.

For some embodiments, the apparatus includes one or more valve supporttissue anchors that are distinct from the valve support and areconfigured to be advanceable along the one or more valve support guidemembers and anchored to the one or more commissures of the valve.

For some embodiments, the one or more valve support anchors includes oneor more ventricular anchors, and the apparatus further includes one ormore atrial anchors, each atrial anchor being configured to be advancedtoward an atrial surface of the valve support and anchor in place thevalve support in a vicinity of a respective one of the ventricularanchors.

For some embodiments, the one or more valve support guide members areremovable from the patient following the anchoring of the valve supportat the atrioventricular valve.

For some embodiments, the one or more valve support tissue anchors areconfigured to be anchored to the one or more commissures fromventricular surfaces thereof prior to advancement of the valve support.

For some embodiments, the one or more valve support tissue anchorsincludes first and second valve support tissue anchors, the first andsecond valve support tissue anchors being configured to be anchored torespective first and second commissures of the atrioventricular valve ofthe patient.

For some embodiments, the one or more valve support tissue anchors eachinclude one or more radially-expandable prongs, and the one or moreprongs are disposed within a sheath in a compressed state prior to theanchoring and exposed from within the sheath in order to expand andfacilitate anchoring of the anchor to the respective commissures.

For some embodiments, the valve support further includes a flexiblegenerally cylindrical element coupled to the annular element andconfigured to be positioned in the native atrioventricular valve of thepatient and to push aside native leaflets of the native valve, thecylindrical element having first and second ends and a cylindrical bodythat is disposed between the first and second ends.

For some embodiments, the cylindrical element includes a flexiblewireframe covered by a fabric.

For some embodiments, the apparatus includes one or more prostheticvalve guide members reversibly couplable to the cylindrical element in avicinity of the second end of the cylindrical element, the prostheticvalve guide members being configured to facilitate advancement of theprosthetic valve therealong and toward the valve support.

For some embodiments, the apparatus includes the prosthetic valve, andthe prosthetic valve is couplable to the valve support.

For some embodiments, the first end of the cylindrical element iscoupled to the annular element, during a first period, the second end ofthe cylindrical element is disposed above the annular element in amanner in which the body of the cylindrical element is disposed abovethe annular element, and the cylindrical element is invertible in amanner in which, during a second period, the second end of thecylindrical element is disposed below the annular element and the bodyof the cylindrical element is disposed below the annular element.

For some embodiments, during the first period, the second end of thecylindrical element is disposed in an atrium of a heart of the patient,the prosthetic valve is advanceable along the one or more prostheticvalve guide members into a ventricle of the heart of the patient, and inresponse to advancement of the prosthetic valve into the ventricle, theone or more prosthetic valve guide members are pulled into the ventricleand pull the second end of the cylindrical element into the ventricle toinvert the cylindrical element.

In accordance with some embodiments of the present disclosure, anapparatus may include one or more valve support guide members configuredto be delivered to one or more commissures of a native atrioventricularvalve of a patient; a prosthetic valve support configured to be advancedtoward the native valve along the one or more valve support guidemembers and placed at the native valve; a prosthetic valve configured tobe coupled to the valve support; and one or more sealing elementsconfigured to facilitate sealing of an interface between the prostheticvalve support and the native valve.

For some embodiments, the sealing element includes a balloon disposedcircumferentially around an outer surface of the prosthetic valvesupport.

For some embodiments, the sealing element includes one or more helicesthat are configured to facilitate sealing of commissures of the nativevalve with respect to the valve support by being wrapped around chordaetendineae of the native valve.

For some embodiments, the sealing element includes grasping elementsthat are configured to facilitate sealing of commissures of the nativevalve with respect to the valve support by grasping the commissures.

For some embodiments, the sealing element is configured to facilitateanchoring of the support to the native valve.

For some embodiments, the valve support is collapsible for transcatheterdelivery and expandable to contact the native atrioventricular valve.

For some embodiments, the prosthetic valve includes two or moreprosthetic leaflets.

For some embodiments, the native atrioventricular valve includes amitral valve, and the prosthetic valve includes three prostheticleaflets.

For some embodiments, the valve support guide members are removable fromthe patient following coupling of the prosthetic valve to the valvesupport.

For some embodiments, the valve support is shaped so as to define adistal portion which is configured to push aside, at least in part,native leaflets of the valve of the patient.

For some embodiments, the valve support is shaped so as to define one ormore holes, the one or more holes being configured to facilitateslidable passage therethrough of a respective one of the one or morevalve support guide members.

For some embodiments, the one or more valve support guide membersincludes one valve support guide member that is looped through first andsecond commissures of the atrioventricular valve in a manner in which alooped portion of the valve support guide member is disposed in aventricle of the patient and first and second free ends of the valvesupport guide member are accessible from a site outside a body of thepatient.

For some embodiments, the apparatus further includes: a guide wireconfigured to be advanced, via the native atrioventricular valve, into aventricle of the patient, and coupled to an inner wall of the patient'sventricle; and a valve support guide member tube coupled to the guidewire, and a distal portion of the valve support guide member isconfigured to loop through the valve support guide member tube, suchthat, in response to the valve support guide member being pusheddistally, portions of the valve support guide member are pushed torespective commissures of the native valve.

For some embodiments, the prosthetic valve is shaped so as to define oneor more protrusions configured to ensnare one or more native leaflets ofthe native valve of the patient.

For some embodiments, the protrusions are disposed in a sinusoidalconfiguration such that the protrusions conform with a saddle shape ofthe patient's native annulus.

For some embodiments, the protrusions are configured to prevent thenative leaflets from interfering with a left ventricular outflow tractof the patient, by sandwiching the leaflets between the protrusions andthe prosthetic valve support.

For some embodiments, the valve support includes: a first end that isconfigured to be placed on an atrial side of a native atrioventricularvalve of a patient; and a second end that is configured, during a firstperiod, to be disposed inside the patient's atrium, above the first endof the valve support, the valve support being at least partiallyinvertible in a manner in which, during a second period, the second endof the valve support is disposed at least partially inside a ventricleof the patient, below the first end of the valve support.

For some embodiments, the valve support includes an annular element anda generally cylindrical element coupled to the annular element, thegenerally cylindrical element being configured to push aside nativeleaflets of the native valve, and the cylindrical element has first andsecond ends and a cylindrical body that is disposed between the firstand second ends.

For some embodiments, the sealing element includes a balloon disposedunderneath the annular element and configured to facilitate sealing ofan interlace between the annular element and the native valve.

For some embodiments, the apparatus further includes one or moreprosthetic valve guide members, the prosthetic valve guide members beingconfigured to facilitate advancement of the prosthetic valve therealongand toward the valve support.

For some embodiments, the first end of the cylindrical element iscoupled to the annular element, during a first period, the second end ofthe cylindrical element is disposed above the annular element in amanner in which the body of the cylindrical element is disposed abovethe annular element, and the cylindrical element is invertible in amanner in which, during a second period, the second end of thecylindrical element is disposed below the annular element and the bodyof the cylindrical element is disposed below the annular element.

For some embodiments, during the first period, the second end of thecylindrical element is disposed in an atrium of a heart of the patientand the annular element is positioned along an annulus of the nativevalve, the prosthetic valve is advanceable along the one or moreprosthetic valve guide members into a ventricle of the heart of thepatient, and in response to advancement of the prosthetic valve into theventricle, the one or more prosthetic valve guide members are pulledinto the ventricle and pull the second end and the body of thecylindrical element into the ventricle to invert the cylindricalelement.

In accordance with some embodiments of the present disclosure, anapparatus may include a prosthetic valve support configured to beadvanced toward a native atrioventricular valve of a patient and placedat the native valve; a prosthetic valve configured to be coupled to thevalve support, the prosthetic valve being shaped so as to define firstand second sets of one or more protrusions, each set of protrusionsconfigured to ensnare a respective native leaflet of the native valve ofthe patient, the first set of protrusions being disposed within a firstcircumferential arc with respect to a longitudinal axis of theprosthetic valve, on a first side of a distal end of the prostheticvalve, the second set of protrusions being disposed within a secondcircumferential arc with respect to the longitudinal axis of theprosthetic valve, on a second side of the distal end of the prostheticvalve, the first and second sets being disposed so as to provide firstand second gaps therebetween at the distal end of the prosthetic valve,at least one of the gaps having a circumferential arc of at least 20degrees; and one or more valve guide members configured to be deliveredto one or ore commissures of the native valve, and to guide the valvesuch that the first and second circumferential arcs are aligned withrespective leaflets of the native valve and such that the first andsecond gaps are aligned with respective commissures of the native valve.

For some embodiments, the at least one of the gaps has a circumferentialare of at least 60 degrees.

For some embodiments, the first circumferential arc defines an angle ofbetween 25 degrees and 90 degrees about the longitudinal axis of theprosthetic valve.

For some embodiments, the second circumferential arc defines an angle ofbetween 25 degrees and 90 degrees about the longitudinal axis of theprosthetic valve.

For some embodiments, the first circumferential arc defines an angle ofbetween 45 degrees and 75 degrees about the longitudinal axis of theprosthetic valve.

For some embodiments, the second circumferential arc defines an angle ofbetween 45 degrees and 75 degrees about the longitudinal axis of theprosthetic valve.

In accordance with some embodiments of the present disclosure, a methodmay include determining an area defined by an annulus of a nativeatrioventricular valve of a patient; selecting a prosthetic valve to beplaced in the native valve by determining that the valve defines across-sectional area that is less than 90% of the area defined by theannulus; and deploying the prosthetic valve at the native valve, theselecting of the prosthetic valve facilitating sealing of the nativevalve with respect to the prosthetic valve by facilitating closing ofleaflets of the native valve around the prosthetic valve, upondeployment of the prosthetic valve.

For some embodiments, selecting the prosthetic valve includes selectinga prosthetic valve having a material disposed on an outer surfacethereof.

For some embodiments, selecting the prosthetic valve includes selectinga prosthetic valve having a material that prevents tissue growthdisposed on an outer surface thereof.

For some embodiments, selecting the prosthetic valve includes selectinga prosthetic valve having a material that promotes tissue growthdisposed on an outer surface thereof.

For some embodiments, selecting the prosthetic valve to be placed in thenative valve includes determining that the valve defines across-sectional area that is less than 80% of the area defined by theannulus.

For some embodiments, selecting the prosthetic valve to be placed in thenative valve includes determining that the valve defines across-sectional area that is less than 60% of the area defined by theannulus.

In accordance with some embodiments of the present disclosure, anapparatus may include a valve support for receiving a prosthetic valve,the valve support including: a first end that is configured to be placedon an atrial side of a native atrioventricular valve of a patient; and asecond end that is configured, during a first period, to be disposedinside the patient's atrium, above the first end of the valve support,the valve support being at least partially invertible in a manner inwhich, during a second period, the second end of the cylindrical elementis disposed at least partially inside a ventricle of the patient, belowthe first end of the valve support.

For some embodiments, the valve support includes a flexible wireframecovered by a fabric.

For some embodiments, the valve support is collapsible for transcatheterdelivery and expandable to contact the native atrioventricular valve.

For some embodiments, the valve support defines a surface that is aninner surface of the valve support during the first period, and an outersurface of the valve support during the second period, and the apparatusfurther includes a sealing material that is disposed on the surface,such that during the second period the sealing material facilitatessealing between the valve support and the native valve.

For some embodiments, the first end includes a coupling elementconfigured to couple the valve support to tissue of the native valve onthe atrial side of the native valve.

For some embodiments, the first end is shaped to define barbs that areconfigured to couple the valve support to tissue of the native valve onthe atrial side of the native valve.

For some embodiments, the valve support includes: an annular elementconfigured to be positioned along a native annulus of the nativeatrioventricular valve; and a flexible generally cylindrical elementconfigured to be positioned in the native atrioventricular valve of thepatient and to push aside native leaflets of the native valve, the firstend of the cylindrical element defining the first end of the valvesupport, and the first end of the cylindrical element being coupled tothe annular element.

For some embodiments, the apparatus further includes one or more valvesupport guide members configured to be delivered to one or morecommissures of the native atrioventricular valve of the patient, and theone or more valve support guide members are configured to facilitateadvancement of the valve support toward the native valve.

For some embodiments, the valve support is shaped so as to define one ormore holes, the one or more holes configured to facilitate slidablepassage therethrough of a respective one of the one or more valvesupport guide members.

For some embodiments, the one or more valve support guide membersincludes one valve support guide member that is looped through first andsecond commissures of the atrioventricular valve in a manner in which alooped portion of the valve support guide member is disposed in aventricle of the patient and first and second free ends of the valvesupport guide member are accessible from a site outside a body of thepatient.

For some embodiments, the apparatus further includes: a guide wireconfigured to be advanced, via the native atrioventricular valve, into aventricle of the patient, and coupled to an inner wall of the patient'sventricle; and a valve support guide member tube coupled to the guidewire, and a distal portion of the valve support guide member isconfigured to loop through the valve support guide member tube, suchthat, in response to the valve support guide member being pusheddistally, portions of the valve support guide member are pushed torespective commissures of the native valve.

For some embodiments, the apparatus further includes one or moreprosthetic valve guide members reversibly couplable to the cylindricalelement in a vicinity of the second end of the cylindrical element, theprosthetic valve guide members being configured to facilitateadvancement of the prosthetic valve therealong and toward the valvesupport.

For some embodiments, the apparatus further includes the prostheticvalve, and the prosthetic valve is couplable to the valve support.

For some embodiments, during the first period, the second end of thecylindrical element is disposed in an atrium of a heart of the patientand the annular element is positioned along an annulus of the nativevalve, the prosthetic valve is advanceable along the one or moreprosthetic valve guide members into a ventricle of the heart of thepatient, and in response to advancement of the prosthetic valve into theventricle, the one or more prosthetic valve guide members are pulledinto the ventricle and pull the second end of the cylindrical elementinto the ventricle to invert the cylindrical element.

For some embodiments, the apparatus further includes one or more sealingelements configured to facilitate sealing of an interface between theprosthetic valve support and the native valve.

For some embodiments, the sealing element includes a balloon disposedcircumferentially around a surface of the prosthetic valve support.

For some embodiments, the sealing element includes one or more helicesthat are configured to facilitate scaling of commissures of the nativevalve with respect to the valve support by being wrapped around chordaetendineae of the native valve.

For some embodiments, the sealing element includes grasping elementsthat are configured to facilitate sealing of commissures of the nativevalve with respect to the valve support by grasping the commissures.

For some embodiments, the sealing element is configured to facilitateanchoring of the support to the native valve.

For some embodiments, the apparatus further includes the prostheticvalve, and the prosthetic valve is couplable to the valve support.

For some embodiments, the prosthetic valve is collapsible fortranscatheter delivery and expandable when exposed from within adelivery catheter.

For some embodiments, the prosthetic valve includes two or moreprosthetic leaflets.

For some embodiments, the native atrioventricular valve includes amitral valve, and the prosthetic valve includes three prostheticleaflets.

For some embodiments, the prosthetic valve is shaped so as to define oneor more protrusions configured to ensnare one or more native leaflets ofthe native valve of the patient.

For some embodiments, the protrusions are disposed in a sinusoidalconfiguration such that the protrusions conform with a saddle shape ofthe patient's native annulus.

For some embodiments, the protrusions are configured to prevent thenative leaflets from interfering with a left ventricular outflow tractof the patient, by sandwiching the leaflets between the protrusions andthe prosthetic valve support.

In accordance with some embodiments of the present disclosure, anapparatus may include a guide wire configured to be advanced into apatient's ventricle via a native atrioventricular valve of the patient,and coupled to an inner wall of the patient's ventricle; a valve supportguide member tube coupled to the guide wire; a valve support guidemember, a distal portion of the valve support guide member loopingthrough the valve support guide member tube, such that, in response tothe valve support guide member being pushed distally, portions of thevalve support guide member are pushed to respective commissures of thenative valve; a prosthetic valve support configured to be advancedtoward the commissures of the native valve along the valve support guidemember portions; and a prosthetic valve configured to be coupled to thevalve support.

For some embodiments, first and second free ends of the valve supportguide member are accessible from a site outside a body of the patient.

For some embodiments, the valve support includes: an annular elementconfigured to be positioned along a native annulus of the nativeatrioventricular valve; and a generally cylindrical element configuredto be positioned in the native atrioventricular valve of the patient andto push aside native leaflets of the native valve, the cylindricalelement being coupled to the annular element, at a first end of thecylindrical element.

For some embodiments, the valve support is shaped so as to define one ormore holes, the one or more holes configured to facilitate slidablepassage therethrough of respective portions of the portions of the valvesupport guide member.

For some embodiments, the guide member is configured to facilitateadvancement of the prosthetic valve therealong and toward the valvesupport.

For some embodiments, the prosthetic valve is collapsible fortranscatheter delivery and expandable when exposed from within adelivery catheter.

For some embodiments, the prosthetic valve includes two or moreprosthetic leaflets.

For some embodiments, the native atrioventricular valve includes amitral valve, and the prosthetic valve includes three prostheticleaflets.

For some embodiments, the guide member is removable from the patientfollowing the coupling of the prosthetic valve to the valve support.

For some embodiments, the prosthetic valve is shaped so as to define oneor more protrusions configured to ensnare one or more native leaflets ofthe native valve of the patient.

For some embodiments, the protrusions are disposed in a sinusoidalconfiguration such that the protrusions conform with a saddle shape ofthe patient's native annulus.

For some embodiments, the protrusions are configured to prevent thenative leaflets from interfering with a left ventricular outflow tractof the patient, by sandwiching the leaflets between the protrusions andthe prosthetic valve support.

For some embodiments, the apparatus further includes one or more sealingelements configured to facilitate sealing of an interface between theprosthetic valve support and the native valve.

For some embodiments, the sealing element includes a balloon disposedcircumferentially around a surface of the prosthetic valve support.

For some embodiments, the sealing element includes one or more helicesthat are configured to facilitate sealing of commissures of the nativevalve with respect to the valve support by being wrapped around chordaetendineae of the native valve.

For some embodiments, the scaling element includes grasping elementsthat are configured to facilitate sealing of commissures of the nativevalve with respect to the valve support by grasping the commissures.

For some embodiments, the sealing element is configured to facilitateanchoring of the support to the native valve.

In accordance with some embodiments of the present disclosure, anapparatus may include one or more valve guide members configured to bedelivered to one or more commissures of a native atrioventricular valveof a patient; a prosthetic valve configured to be advanced to beadvanced toward the native valve along the one or more valve guidemembers and placed at the native valve at at least the one or morecommissures; and one or more proximally-facing grasping elements thatare configured to facilitate sealing of commissures of the native valvewith respect to the valve by: being inserted into a ventricle of thepatient; and being pulled proximally and being closed around tissue in avicinity of the commissures.

For some embodiments, the grasping elements include two surfaces thatare hingedly coupled to one another, and that are configured tofacilitate the sealing of the commissures of the native valve withrespect to the prosthetic valve by being closed about the hinge withrespect to one another.

In accordance with some embodiments of the present disclosure, a methodmay include advancing one or more valve support guide members toward oneor more commissures of a native atrioventricular valve of a patient;placing a prosthetic valve support at the native atrioventricular valveby advancing the valve support along the one or more valve support guidemembers; coupling a prosthetic valve to the prosthetic valve support;and facilitating sealing of an interface between the prosthetic valvesupport and the native valve by deploying a sealing element in avicinity of the interface.

In accordance with some embodiments of the present disclosure, a methodmay include placing a first end of a prosthetic valve support on anatrial side of a native atrioventricular valve of a patient, such that asecond end of the valve support is disposed, during a first period,inside the patient's atrium, above the first end of the valve support;and subsequent to the placing of the valve support, inverting at least aportion of the valve support such that, during a second period, thesecond end of the valve support is disposed at least partially inside aventricle of the patient, below the first end of the valve support.

In accordance with some embodiments of the present disclosure, a methodmay include advancing a guide wire, via a native atrioventricular valve,into a ventricle of the patient, a valve support guide member tube beingcoupled to the guide wire; coupling a distal end of the guide wire to aninner wall of the patient's ventricle; and causing portions of a valvesupport guide member to be pushed to respective commissures of thenative valve, by pushing the guide member distally, a distal portion ofthe valve support guide member looping through the valve support guidemember tube; advancing a prosthetic valve support toward the commissuresof the native valve along the valve support guide member portions; andcoupling a prosthetic valve to the valve support.

In accordance with some embodiments of the present disclosure, a methodmay include advancing one or more valve guide members toward one or morecommissures of a native atrioventricular valve of a patient; placing aprosthetic valve at the native atrioventricular valve by advancing thevalve along the one or more valve guide members; and facilitatingsealing of commissures of the native valve with respect to the valve by:inserting into a ventricle of the patient one or more grasping elementsthat are coupled to the prosthetic valve; pulling the grasping elementsproximally; and closing the grasping elements around tissue in avicinity of the commissures.

The present disclosure will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-B are schematic illustrations of advancement of one or moreguide members toward respective commissures of a mitral valve, inaccordance with some embodiments of the present disclosure;

FIGS. 1C-D are schematic illustrations of the advancement and deploymentof commissural anchors via the guide members, in accordance with someembodiments of the present disclosure;

FIGS. 2A-D are schematic illustrations of the advancement of aprosthetic valve support toward a native atrioventricular valve of apatient, in accordance with some embodiments of the present disclosure;

FIGS. 2E-F are schematic illustrations of locking of the prostheticvalve support at the native valve, in accordance with some embodimentsof the present disclosure;

FIGS. 2G-K are schematic illustrations of the advancement of aprosthetic valve and the coupling of the prosthetic valve to the valvesupport, in accordance with some embodiments of the present disclosure;

FIGS. 3A-B are schematic illustrations of the advancement of aprosthetic valve support toward a native atrioventricular valve of apatient, the valve support including a sealing balloon, in accordancewith some embodiments of the present disclosure;

FIGS. 3C-D are schematic illustrations of locking of the prostheticvalve support at the native valve, the valve support including thesealing balloon, in accordance with some embodiments of the presentdisclosure;

FIGS. 4A-C are schematic illustrations of a valve support being usedwith commissural helices that facilitate anchoring and/or sealing of thevalve support, in accordance with some embodiments of the presentdisclosure;

FIGS. 5A-D are schematic illustrations of grasping elements being usedto anchor and/or provide sealing of a prosthetic valve, in accordancewith some embodiments of the present disclosure;

FIGS. 6A-B are schematic illustrations of a prosthetic valve thatincludes a sealing material, in accordance with some embodiments of thepresent disclosure;

FIGS. 7A-F are schematic illustrations of a guide wire delivery system,in accordance with some embodiments of the present disclosure;

FIGS. 8A-C are schematic illustrations of a valve support that has acylindrical element that is invertible, in accordance with someembodiments of the present disclosure;

FIGS. 9A-D are schematic illustrations of the advancement of aninvertible prosthetic valve support toward a native atrioventricularvalve of a patient, in accordance with some embodiments of the presentdisclosure;

FIG. 9E is a schematic illustration of inversion of the invertibleprosthetic valve support at the native valve, in accordance with someembodiments of the present disclosure;

FIGS. 9F-H are schematic illustrations of the advancement of aprosthetic valve and the coupling of the prosthetic valve to theinvertible valve support, in accordance with some embodiments of thepresent disclosure;

FIG. 10 is a schematic illustration of a prosthetic valve, thecross-sectional area of which is smaller than the area defined by thepatient's native valve annulus, in accordance with some embodiments ofthe present disclosure;

FIGS. 11A-D are schematic illustrations of a prosthetic valve thatdefines protrusions from portions of the distal end of the valve, inaccordance with some embodiments of the present disclosure;

FIGS. 12A-C are schematic illustrations of a prosthetic valve thatdefines distal protrusions that are disposed sinusoidally around thecircumference of the valve, in accordance with some embodiments of thepresent disclosure;

FIGS. 13A-E are schematic illustrations of respective configurations ofa frame of a prosthetic valve, in accordance with some embodiments ofthe present disclosure;

FIGS. 14A-D are schematic illustrations of respective configurations ofa prosthetic valve support, in accordance with some embodiments of thepresent disclosure;

FIGS. 15A-E are schematic illustrations of respective steps of aprocedure for deploying a prosthetic valve, in accordance with someembodiments of the present disclosure;

FIGS. 16A-H are schematic illustrations of respective steps of analternative procedure for deploying a prosthetic valve, in accordancewith some embodiments of the present disclosure;

FIGS. 17A-C are schematic illustrations of leaflets of a prostheticvalve, in accordance with some embodiments of the present disclosure;

FIGS. 18A-B are schematic illustrations of a valve support coupled to aplurality of tissue anchors, in accordance with some embodiments of thepresent disclosure;

FIGS. 19A-D are schematic illustrations of the valve support of FIGS.18A-B being implanted in the native valve of the patient andfacilitating implantation of a prosthetic valve, in accordance with someembodiments of the present disclosure; and

FIGS. 20A-B are schematic illustrations of a prosthetic valve and aprosthetic valve support deployed, respectively, at a tricuspid valve,and at an aortic valve, in accordance with some embodiments of thepresent disclosure.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Reference is now made to FIGS. 1A-B, which are schematic illustrationsof a system 20 for replacing an atrioventricular valve 5 of a patientincluding one or more guide members 21 a and 21 b which are advancedtoward first and second commissures 8 and 10 of valve 5 of a heart 2 ofthe patient, in accordance with some embodiments of the presentdisclosure. For some embodiments, guide members 21 a and 21 b includedistinct guide members. Alternatively (as shown in FIGS. 7A-F), only oneguide member is looped through commissures 8 and 10 in a manner in whichthe guide member defines a looped portion between commissures 8 and 10(i.e., a portion of the guide member that is disposed in a ventricle 6of heart 2), and first and second free ends which are disposed andaccessible at a site outside the body of the patient. For suchembodiments, the guide member defines portions 21 a and 21 b.

It is noted that for embodiments in which valve 5 is the patient'smitral valve, first and second commissures 8 and 10 are the anterior andposterior commissures. For embodiments in which valve 5 is the patient'stricuspid valve (which includes three commissures), the first and secondcommissures may be the anterior and posterior commissures of thetricuspid valve.

For some embodiments, guide members 21 a and 21 b include guide wireshaving a diameter of 0.035 inches.

The transcatheter procedure in some embodiments begins with theadvancing of a semi-rigid guide wire into a right atrium 4 of thepatient. The semi-rigid guide wire provides a guide for the subsequentadvancement of a sheath 25 therealong and into the right atrium. Oncesheath 25 has entered the right atrium, the semi-rigid guide wire isretracted from the patient's body. Sheath 25 in some embodimentsincludes a 13-20 F sheath, although the size may be selected asappropriate for a given patient. Sheath 25 is advanced throughvasculature into the right atrium using a suitable point of origin insome embodiments determined for a given patient. For example: sheath 25may be introduced into the femoral vein of the patient, through aninferior vena cava, into the right atrium, and into the left atriumtransseptally, in some embodiments through the fossa ovalis; sheath 25may be introduced into the basilic vein, through the subclavian vein tothe superior vena cava, into the right atrium, and into the left atriumtransseptally, in some embodiments through the fossa ovalis; or sheath25 may be introduced into the external jugular vein, through thesubclavian vein to the superior vena cava, into the right atrium, andinto the left atrium transseptally, in some embodiments through thefossa ovalis.

In some embodiments of the present disclosure, sheath 25 is advancedthrough the inferior vena cava of the patient and into the right atriumusing a suitable point of origin in some embodiments determined for agiven patient.

Sheath 25 is advanced distally until sheath 25 reaches the interatrialseptum. For some embodiments, a resilient needle and a dilator (notshown) are advanced through the sheath and into the heart. In order toadvance the sheath transseptally into the left atrium, the dilator isadvanced to the septum, and the needle is pushed from within the dilatorand is allowed to puncture the septum to create an opening thatfacilitates passage of the dilator and subsequently the sheaththerethrough and into the left atrium. The dilator is passed through thehole in the septum created by the needle. In some embodiments, thedilator is shaped to define a hollow shaft for passage along the needle,and the hollow shaft is shaped to define a tapered distal end. Thistapered distal end is first advanced through the hole created by theneedle. The hole is enlarged when the gradually increasing diameter ofthe distal end of the dilator is pushed through the hole in the septum.

The advancement of sheath 25 through the septum and into the left atriumis followed by the extraction of the dilator and the needle from withinsheath 25.

FIGS. 1C-D and 2A-B show advancement of one or more tissue anchors 30 aand 30 b (alternatively, “tissue anchor bases 30 a and 30 b”) alongguide members 21 a and 21 b, respectively. Tissue anchor bases 30 a and30 b include a flexible, biocompatible material (e.g., nitinol) andinclude one or more (e.g., a plurality of) radially-expandable prongs 32(alternatively, “leaves 32”) which may include, e.g., barbs. Each tissueanchor base 30 a and 30 b is reversibly coupled to a respective deliverymechanism, such as delivery lumen 27 a and 27 b. Each delivery lumen 27slides around a respective guide member 21. A respective surroundingsheath 26 a and 26 b surrounds each delivery lumen 27 a and 27 b andaround tissue anchor bases 30 a and 30 b at least in part in order tocompress and prevent expansion of the leaves 32 of tissue anchor bases30 a and 30 b.

As shown in FIG. 1D, the distal ends of lumens 27 a and 27 b arereversibly coupled to ribbed crimping structures 34. As describedhereinbelow, tissue anchor bases 30 a and 30 b are anchored toventricular surfaces of commissures 8 and 10. Following the anchoring,ribbed crimping structures 34 extend from tissue anchor bases 30 a and30 b through commissures 8 and 10, respectively, and toward the atrialsurfaces of commissures 8 and 10. Ribbed crimping structures 34 areconfigured to facilitate anchoring of a valve support (describedhereinbelow) to the atrial surfaces of commissures 8 and 10. Tissueanchor bases 30 and crimping structures 34 may together constitute atissue anchor 35, which may be configured to anchor a valve support (viaengagement of the valve support with crimping structures 34) to theventricular surfaces of commissures 8 and 10 (via anchor bases 30).

Anchor bases 30 a and 30 b, ribbed crimping structures 34, and thedistal ends of surrounding sheaths 26 a and 26 b are advanced intoventricle 6. Subsequently, anchor bases 30 a and 30 b are pusheddistally from within sheaths 26 a and 26 b, (or sheaths 26 a and 26 bare pulled proximally with respect to anchor bases 30 a and 30 b) toexpose anchor bases 30 a and 30 b. As anchor bases 30 a and 30 b areexposed from within sheaths 26 a and 26 b, leaves 32 are free to expandand splay outward, as shown in FIG. 1D. Leaves 32 expand such thatanchor bases 30 a and 30 b assume a flower shape. Leaves 32,collectively in their expanded state, create a larger surface area toengage tissue than in their compressed states. Following the exposing ofanchor bases 30 a and 30 b, sheaths 26 a and 26 b are extracted.

As shown in FIG. 2B, lumens 27 a and 27 b are pulled proximally so thatleaves 32 of anchor bases 30 a and 30 b engage respective ventricularsurface of commissures 8 and 10. Leaves 32 create a large surface areawhich restricts proximal motion of anchor bases 30 a and 30 b fromcommissures 8 and 10, respectively.

For some embodiments, following the anchoring of anchor bases 30 a and30 b to commissures 8 and 10, respectively, guide members 21 a and 21 bare removed from the body of the patient.

Reference is now made to FIGS. 2C-F, which are schematic illustrationsof the advancement of a prosthetic valve support 40 (alternatively,“annular spacer 40”) along lumens 27 a and 27 b, in accordance with someembodiments of the present disclosure. In such a manner, lumens 27 a and27 b function as spacer guide members. As illustrated in FIG. 2D, spacer40 may be annular, with a spacer opening 47 extending therethrough.Spacer 40 is collapsible and includes a proximal annular element 44(alternatively, “wall 44”) and a distal cylindrical element 42(alternatively, “cylindrical skirt 42”). As illustrated in FIG. 2D, insome embodiments wall 44 may be substantially flattened or planar, thusrendering wall 44 disc-shaped. As also illustrated in FIG. 2D, an outerdiameter of cylindrical skirt 42 may be smaller than an outer diameterof disc-shaped wall 44. Spacer opening 47 may extend through disc-shapedwall 44 and cylindrical skirt 42. Thus, spacer opening 47 may define aninner diameter of disc-shaped wall 44 and cylindrical skirt 42. Spacer40 is configured to assume a collapsed state (e.g., surrounded by asheath or overtube 50 shown in FIG. 20) for minimally-invasive deliveryto the diseased native valve, such as by percutaneous or transluminaldelivery using one or more catheters. FIG. 2C and the other figures showspacer 40 in an expanded state after delivery in right atrium 4 andadvancement toward the native valve. As shown in FIG. 2D, spacer 40 isshaped so as to define one or more (e.g., two, as shown in View A) holes46 a and 46 b for slidable advancement of spacer 40 along lumens 27 aand 27 b, respectively. That is, prior to introduction of spacer 40 intothe body of the patient, lumens 27 a and 27 b are threaded through holes46 a and 46 b, respectively, and spacer 40 is slid along lumens 27 a and27 b. Spacer 40 is slid by pushing elements 52 a and 52 b which surrounddelivery lumens 27 a and 27 b, respectively.

It is to be noted that spacer 40 is slid along lumens 27 a and 27 b byway of illustration and not limitation. That is, for some embodiments,following the anchoring of tissue anchor bases 30 a and 30 b tocommissures 8 and 10, respectively, guide members 21 a and 21 b are notremoved from the body of the patient, but rather lumens 27 a and 27 bare removed (e.g., by being decoupled from crimping structures 34)leaving behind tissue anchor bases 30 a and 30 b and guide members 21 aand 21 b. Guide members 21 a and 21 b may then be threaded through holes46 a and 46 b, respectively, and spacer 40 is slid along guide members21 a and 21 b. In such a manner, guide members 21 a and 21 b function asspacer guide members.

Spacer 40 includes a collapsible flexible support stent 48, which is atleast partially covered by a covering 49. Spacer 40 is configured to beplaced at native valve 5, such that cylindrical skirt 42 passes throughthe orifice of the native valve and extends towards, and, in someembodiments partially into, ventricle 6 (as shown in FIG. 2E). Sincecylindrical skirt 42 may be configured to sit within the orifice of thenative valve, spacer 40 may be configured such that spacer opening 47(which defines the inner diameter of cylindrical skirt 42) may have asmaller diameter than the native valve orifice. For example, asillustrated in FIG. 2E, spacer 40 may be configured such that spaceropening 47 may have a smaller diameter than native annulus 11.Cylindrical skirt 42 in some embodiments pushes aside and pressesagainst native leaflets of native valve 5 at least in part, which areleft in place during and after implantation of the central valve section80. Disc-shaped wall 44 is configured to be placed around a nativeannulus 11 of the native valve, and to extend at least partially into anatrium 4 such that disc-shaped wall 44 rests against the native annulus.Disc-shaped wall 44 is in some embodiments too large to pass through theannulus, and may, for example, have an outer diameter of between 30 and60 mm.

For some embodiments, collapsible support stent 48 includes a pluralityof struts. As illustrated in FIG. 2D, stent 48 may include struts 48 apositioned within disc-shaped wall 44 and struts 48 b positioned withincylindrical skirt 42. The struts may include, for example, a metal suchas nitinol or stainless steel. For some embodiments, stent 48 includes aflexible metal, e.g., nitinol, which facilitates compression of spacer40 within a delivery sheath or overtube 50. For some embodiments,covering 49 includes a fabric, such as a woven fabric, e.g., Dacron.Covering 49 is in some embodiments configured to cover at least aportion of cylindrical skirt 42, and at least a portion of disc-shapedwall 44. The covering may include a single piece, or a plurality ofpieces sewn together. Disc-shaped wall 44 may be configured to at leastpartially obstruct blood flow therethrough due, at least in part, to thepresence of stent 48 and/or due to the arrangement of covering 49 uponstent 48.

As shown in FIG. 2D, pushing elements 52 a and 52 b are each coupled tolocking crimping elements 64 a and 64 b, respectively. Locking crimpingelements 64 a and 64 b are disposed adjacently, proximally to holes 46 aand 46 b respectively of spacer 40. These techniques enable the surgeonto readily bring crimping elements 64 a and 64 b to the appropriatesites along disc-shaped wall 44, without the need for excessive imaging,such as fluoroscopy.

FIG. 2E shows spacer 40 prior to implantation at annulus 11. As shown,ribbed crimping structures 34 project away from tissue anchor bases 30 aand 30 b, through commissures 8 and 10, and toward atrium 4. Spacer 40is advanced along lumens 27 a and 27 b toward structures 34 by beingpushed by pushing elements 52 a and 52 b and locking crimping elements64 a and 64 b.

In FIG. 2F, spacer 40 is further pushed by pushing elements 52 a and 52b and locking crimping elements 64 a and 64 b such that holes 46 a and46 b of spacer 40 advance around ribbed crimping structures 34. As holes46 a and 46 b are advanced around ribbed crimping structures 34, lockingcrimping elements 64 a and 64 b advance over and surround ribbedcrimping elements 34 to lock in place spacer 40 from an atrial surfaceof valve 5.

Responsively to the placement of spacer 40 at native valve 5,cylindrical skirt 42 is positioned partially within ventricle 6 andnative leaflets 12 and 14 of native valve 5 are pushed aside.

As shown in section A-A, ribbed crimping structures 34 of tissue anchors35 are shaped so as to define a plurality of male couplings. Lockingcrimping elements 64 a and 64 b each include a cylindrical elementhaving an inner lumen that is shaped so as to surround a respectiveribbed crimping structure 34. Each inner lumen of locking crimpingelements 64 a and 64 b is shaped so as to define female couplings toreceive the male couplings of ribbed crimping structure 34. The femalecouplings of locking crimping element 64 are directioned such that theyfacilitate distal advancement of locking crimping element 64 whilerestricting proximal advancement of locking crimping element 64. Whenthe female couplings of locking crimping element 64 receive the malecouplings of ribbed crimping structure 34, spacer 40 is locked in placefrom an atrial surface of valve 5. It is to be noted that for someembodiments, ribbed crimping elements 34 include female couplings, andlocking crimping elements 64 include male couplings.

Reference is now made to FIGS. 2G-K which are schematic illustrations ofthe coupling of a central valve section 80 to spacer 40, in accordancewith some embodiments of the present disclosure. Spacer 40 receives thecentral valve section 80 within spacer opening 47 and functions as adocking station. Thus, the docking station is a coupling element thatprovides coupling between two other elements (in this case, betweenannulus 11 and central valve section 80.)

Following the placement of spacer 40 at annulus 11, pushing elements 52a and 52 b and sheath or overtube 50 are removed from the body of thepatient, leaving behind lumens 27 a and 27 b, as shown in FIG. 2G.

As shown in FIG. 2G, a guide wire 72 is advanced toward ventricle 6 andfacilitates the advancement of an overtube 70 through sheath 25 and thepositioning of a distal end of overtube 70 within ventricle 6. Overtube70 facilitates the advancement of central valve section 80 in acompressed state, toward spacer 40.

FIG. 2H shows partial deployment of central valve section 80 withinventricle 6 of heart 2. Central valve section 80 is shown including anexpandable frame 79 including a plurality of stent struts 79 a by way ofillustration and not limitation. The wireframe of central valve section80 includes a flexible metal, e.g., nitinol or stainless steel. It is tobe noted that the wireframe of central valve section 80 is covered by acovering (not shown for clarity of illustration) including a braidedmesh or in a fabric such as a woven fabric, e.g., Dacron. The coveringis in some embodiments configured to cover at least a portion of theframe. The covering may include a single piece, or a plurality of piecessewn together. Expandable frame 79 is in some embodimentsself-expandable, although the scope of the present disclosure includesusing a prosthetic valve that includes a balloon expandable frame,mutatis mutandis.

Following the partial deployment of central valve section 80 inventricle 6, overtube 70 is pulled proximally to pull central valvesection 80 proximally such that cylindrical skirt 42 and/or disc-shapedwall 44 of spacer 40 surrounds a proximal portion of central valvesection 80. Central valve section 80 may be configured to expand suchthat central valve section 80, in particular cylindrical portion 86thereof, is held in place with respect to spacer 40 responsively toradial forces acted upon spacer 40 by central valve section 80. Becausespacer 40 and central valve section 80 are configured to be implantedseparately and to engage one another within the body, spacer 40 andcentral valve section 80 may be separable such that the features can bedisengaged (e.g. by contracting central valve section 80 and removing itfrom spacer 40. In addition, and as illustrated in FIG. 2J, an outerdiameter of cylindrical portion 86 of the central valve section may besmaller than the diameter of native annulus 11 due, at least in part, tothe engagement between expanded cylindrical portion 86 and spacer 40.

Central valve section 80 includes a plurality of distal protrusions 84(e.g., snares). As illustrated in FIGS. 2I and 2J, protrusions 84 areconfigured to extend radially outward beyond cylindrical skirt 42 of theannular spacer. When central valve section 80 is pulled proximally, asdescribed hereinabove, protrusions 84 ensnare and engage the nativeleaflets of the atrioventricular valve. By the ensnaring of the nativeleaflets, protrusions 84 sandwich the native valve between protrusions84 and spacer 40. Such ensnaring helps further anchor central valvesection 80 to the native atrioventricular valve. The scope of thepresent disclosure includes using any sort of protrusions (e.g., hooks)that protrude from the distal end of expandable frame 79 of centralvalve section 80 and that are configured such that the native valve issandwiched between the protrusions and spacer 40. In some embodiments,the protrusions cause sandwiching of the native valve leaflets, suchthat the leaflets do not interfere with the left ventricular outflowtract (LVOT).

For some embodiments, protrusions 84 are such as to (a) prevent proximalmigration of the central valve section into the patient's atrium, while(b) allowing movement of the native leaflets with respect to the frameof the central valve section. For example, the protrusions may have theaforementioned functionalities by having lengths of less than 5 mm,and/or by a total width of each set of protrusions corresponding torespective leaflets of the native valve being less than 5 mm. Forexample, the central valve section may include a single protrusioncorresponding to each leaflet of the native valve, the width of each ofthe single protrusions being less than 1 mm. Thus, the central valvesection may be stopped from proximally migrating into the atrium, by theprotrusions preventing the distal end of the central valve section frommigrating further proximally than edges of native leaflets of the valve.Furthermore, the protrusions may allow movement of the native leafletswith respect to the frame of the central valve section by not generallysqueezing the native leaflets between the protrusions and the frame ofthe central valve section. For some embodiments, by allowing movement ofthe native leaflets with respect to the frame of the central valvesection, sealing of the native leaflets against the outer surface of theframe of the central valve section is facilitated, in accordance withthe techniques described hereinbelow with reference to FIG. 10. In someembodiments, spacer 40 prevents the central valve section from migratingdistally into the patient's ventricle.

For some embodiments, during the procedure, the central valve section ispulled back proximally with respect to the annular spacer, as describedhereinabove. The central valve section is pulled back to a position withrespect to the annular spacer that is such that protrusions 84 preventthe native leaflets from interfering with the LVOT, by sandwiching thenative leaflets between the protrusions and the annular spacer, and/orby anchoring ends of the native leaflets as described hereinabove. Thecentral valve section is then deployed at this position.

For some embodiments, protrusions are disposed on the central valvesection on the sides of the central valve section that are adjacent tothe anterior and posterior leaflets of the native valve, and the centralvalve section does not includes protrusions on the portions of thecentral valve section that are adjacent to the commissures of the nativevalve, as described with reference to FIGS. 11A-D. For some embodiments,the protrusions are disposed in a sinusoidal configuration in order toconform with the saddle shape of the native valve, as describedhereinbelow with reference to FIGS. 12A-C.

Additionally, as shown in FIG. 2J, central valve section 80 includes oneor more (e.g., a plurality, as shown) coupling elements 81 at theproximal end of central valve section 80. Overtube 70, which facilitatesthe advancement of central valve section 80, is reversibly coupled tocentral valve section 80, via coupling elements 81.

Central valve section 80 is configured for implantation in and/or atleast partial replacement of a native atrioventricular valve 5 of thepatient, such as a native mitral valve or a native tricuspid valve.Central valve section 80 is configured to assume a collapsed state forminimally-invasive delivery to the diseased native valve, such as bypercutaneous or transluminal delivery using one or more catheters. FIG.2J shows central valve section 80 in an expanded state after delivery tothe native valve.

Reference is now made to FIG. 2K which shows a bird's-eye view ofcentral valve section 80. Central valve section 80 further includes aplurality of valve leaflets 82, which may be artificial or tissue-based.The leaflets are in some embodiments coupled to an inner surface of thecentral valve section. Leaflets 82 are coupled, e.g., sewn, toexpandable frame 79 and/or to the covering. For embodiments in which thecentral valve section is configured to be implanted at the native mitralvalve, the central valve section in some embodiments includes threeleaflets 82 a, 82 b, and 82 c, as shown in FIG. 2K.

Reference is now made to FIGS. 3A-D, which are schematic illustrationsof the advancement of spacer 40 toward native atrioventricular valve 5of a patient, the annular spacer including a sealing balloon 90, inaccordance with some embodiments of the present disclosure. The stepsshown in FIGS. 3A-C are generally similar to those shown in FIGS. 2C-F.For some embodiments, sealing balloon 90 is disposed on thevalve-facing, lower side of disc-shaped wall 44 of the annular spacer.FIG. 3D shows spacer 40, the spacer having been implanted at annulus 11.In some embodiments, at this stage, balloon 90 is inflated, as shown inthe transition from FIG. 30 to FIG. 3D. The balloon is inflated via aninflation lumen 92, shown in FIG. 3C, for example. For some embodiments,the balloon seals the interface between the spacer and native annulus11, thereby reducing retrograde blood flow from ventricle 6 into atrium4, relative to retrograde blood flow in the absence of a sealingballoon. For some embodiments, the balloon is inflated prior to theplacement of the prosthetic support at annulus 11.

Reference is now made to FIGS. 4A-C, which are schematic illustrationsof spacer 40 being used with commissural helices 100 a and 100 b thatfacilitate anchoring and/or sealing of the spacer, in accordance withsome embodiments of the present disclosure. For some embodiments,commissural helices are used as an alternative or in addition to tissueanchor bases 30 a and 30 b and/or other anchoring elements describedherein, in order to facilitate the anchoring of spacer 40.

Commissural helices 100 a and 100 b are in some embodiments placed atcommissures 8 and 10 in a generally similar technique to that describedwith reference to tissue anchor bases 30 a and 30 b. In someembodiments, each helix 30 a and 30 b is reversibly coupled to arespective delivery lumen 27 a and 27 b. As described above, eachdelivery lumen 27 slides around a respective guide member 21, and arespective surrounding sheath 26 a and 26 b surrounds each deliverylumen 27 a and 27 b.

Commissural helices 100 a and 100 b (optionally, ribbed crimpingstructures 34), and the distal ends of surrounding sheaths 26 a and 26 bare advanced into ventricle 6. The helices are pushed out of the distalends of surrounding sheaths 26 a and 26 b. Subsequently, the helices arerotated proximally such that the helices wrap around at least somechordae tendineae 102 of the patient. Following the advancement of thehelices out of sheaths 26 a and 26 b, the sheaths are extracted. Forsome embodiments the helices are conical helices (as shown), and thewider end of the conical helix is disposed at the proximal end of thehelix.

Subsequent to the placement of commissural helices 100 a and 100 baround the chordae tendineae, spacer 40 is placed at annulus 11, inaccordance with the techniques described hereinabove, and as shown inFIG. 4B. Subsequently, central valve section 80 is coupled to spacer 40,in accordance with the techniques described hereinabove, and as shown inFIG. 4C.

In some embodiments, commissural helices 100 a and 100 b facilitatesealing of native commissures 8 and 10, thereby reducing retrogradeblood flow via the commissures, relative to retrograde blood flow in theabsence of the helices. Further in some embodiments, the sealing of thenative commissures facilitates anchoring of the spacer to native valve5.

Reference is now made to FIGS. 5A-D, which are schematic illustrationsof grasping elements 106 a and 106 b being used to anchor central valvesection 80, in accordance with some embodiments of the presentdisclosure. For some embodiments, guide members 21 a and 21 b areadvanced toward first and second commissures 8 and 10 of valve 5 of thepatient, as described hereinabove. Grasping elements 106 a and 106 b arereversibly coupled to distal ends of delivery lumen 27 a and 27 b, thedelivery lumens being advanced over respective guide members, asdescribed hereinabove. For some embodiments, the guiding members and thegrasping elements are advanced toward the patient's commissures viasurrounding sheaths 26 a and 26 b, the surrounding sheaths beinggenerally as described hereinabove. The grasping elements are in someembodiments placed distally to the commissures in a proximally-facingconfiguration, as shown in FIG. 5A. For example, as shown, the graspingelements may be configured to be proximally facing due to the couplingof the grasping elements to the guide members.

Subsequent to the placement of grasping elements 106 a and 106 bdistally to native commissures 8 and 10, central valve section 80 isadvanced toward native valve 5, as shown in FIG. 5B. For example, thecentral valve section may be advanced over delivery lumens 27 a and 27b, as shown. The central valve section is placed at the native valveand, subsequently, the grasping elements are retracted proximally towardcommissures 8 and 10, as shown in the transition from FIG. 5B to FIG.5C. For some embodiments, the grasping elements are coupled to centralvalve section 80 via coupling tubes 107 a and 107 b, the coupling tubesbeing coupled to the sides of the central valve section, as shown. Thegrasping elements are closed such that the native commissures aregrasped and sealed by the grasping elements, as shown in FIG. 5D. Insome embodiments, the grasping elements define two surfaces that arehingedly coupled to each other. For example, the grasping elements mayinclude forceps, as shown. The grasping elements are closed by closingthe surfaces about the hinge, with respect to one another.

In some embodiments, grasping elements 106 a and 106 b facilitatesealing of native commissures 8 and 10, thereby reducing retrogradeblood flow via the commissures, relative to retrograde blood flow in theabsence of the grasping elements. Further in some embodiments, thesealing of the native commissures facilitates anchoring of the centralvalve section to native valve 5.

Although not shown, for some embodiments, spacer 40 is used in additionto grasping elements 106 a and 106 b, in order to anchor central valvesection 80 to native valve 5. For some embodiments, the graspingelements are used to anchor and/or provide sealing for spacer 40(instead of, or in addition to, being used to anchor central valvesection 80, as shown). For such embodiments, generally similartechniques are used to those described with respect to the use of thegrasping elements for anchoring the central valve section, mutatismutandis.

Reference is now made to FIGS. 6A-B, which are schematic illustrationsof central valve section 80, the central valve section including asealing material 110 on an outer surface of the central valve section,in accordance with some embodiments of the present disclosure. For someembodiments, central valve section 80 is used in conjunction with spacer40, as described hereinabove. The techniques for implanting centralvalve section 80 as shown in FIGS. 6A-B are generally similar to thosedescribed hereinabove. In some embodiments, sealing material 110 sealsthe interface between the central valve section and native valve 5. Thescaling material reduces retrograde blood flow from ventricle 6 intoatrium 4, relative to retrograde blood flow in the absence of thesealing material. In some embodiments, the sealing material is composedof latex, dacron, and/or any other suitable biocompatible material. Thesealing material is in some embodiments placed around at least a portionof expandable frame 79 of the central valve section so as to form awebbing between struts 79 a of the expandable frame.

Reference is now made to FIGS. 7A-F, which are schematic illustrationsof a guide wire delivery system, in accordance with some embodiments ofthe present disclosure. As described hereinabove (e.g., with referenceto FIGS. 2C-F), for some embodiments, guide members 21 a and 21 b,function as spacer guide members, by spacer 40 being slid along guidemembers 21 a and 21 b. For some embodiments, only one guide member 21 islooped through commissures 8 and 10 in a manner in which the guidemember defines a looped portion between commissures 8 and 10 (i.e., aportion of the guide member that is disposed in a ventricle 6 of heart2), and first and second free ends, which are disposed and accessible ata site outside the body of the patient. For such embodiments, the guidemember defines portions 21 a and 21 b.

For some embodiments, an anchor base 302 is advanced toward the vicinityof apex 304 of heart 2, via sheath 25, and is anchored to the vicinityof the apex, as shown in FIG. 7A. A guidewire 306 extends proximallyfrom the anchor base 302. Guide member 21 passes through a guide membertube 320, the guide member tube being coupled to guidewire 306. Guidemember 21 is pushed distally. Guide member tube 320 is unable to advancedistally over guidewire 306, due to the coupling of the guide membertube to the guidewire. Therefore, the pushing of guide member 21distally, causes portions 21 a and 21 b to spread apart from one anotherand to be pushed against commissures 8 and 10 of native valve 5.Portions 21 a and 21 b are then used to guide spacer 40 to thecommissures, as shown in FIGS. 7B-C, using generally similar techniquesto those described hereinabove, except for the differences describedhereinbelow.

As shown in FIG. 7B, spacer 40 is slid over guide member portions 21 aand 21 b, by pushing elements 52 a and 52 b. Since the guide memberportions are positioned at commissures 8 and 10, the guide memberportions guide the distal ends of pushing elements 52 a and 52 b, suchthat the pushing elements push the spacer against the commissures, asshown in FIG. 7C.

Subsequent to the placement of spacer 40 at the native valve, centralvalve section 80 is coupled to spacer 40. For some embodiments, pushingelements 52 a and 52 b continue to push the spacer against the nativevalve, during the coupling of the central valve section to the spacer.As described hereinabove, overtube 70 is advanced into ventricle 6, asshown in FIG. 70. FIG. 7E shows central valve section having beenpartially deployed in the ventricle. Following the partial deployment ofcentral valve section 80 in ventricle 6, overtube 70 is pulledproximally to pull central valve section 80 proximally such thatcylindrical skirt 42 and/or disc-shaped wall 44 of spacer 40 surrounds aproximal portion of central valve section 80. Central valve section 80may be configured to expand such that central valve section 80 is heldin place with respect to spacer 40 responsively to radial forces actedupon spacer 40 by central valve section 80. During the pulling back ofovertube 70, pushing elements 52 a and 52 b push spacer 40 against thecentral valve section, thereby providing a counter force against whichovertube 70 is pulled back. For some embodiments, the pushing of thespacer against the commissures is such that it is not necessary to useanchors for anchoring the spacer to the native valve during the couplingof the central valve section to the spacer. Alternatively, in additionto the pushing elements providing a counter force against which thecentral valve section is pulled, anchors are used to anchor the spacerto the native valve during the coupling of the central valve section tothe spacer.

As described hereinabove, central valve section 80 includes a pluralityof distal protrusions 84. When central valve section 80 is pulledproximally, as described hereinabove, protrusions 84 ensnare and engagethe native leaflets of the atrioventricular valve. By the ensnaring ofthe native leaflets, protrusions 84 sandwich the native valve betweenprotrusions 84 and spacer 40. Such ensnaring helps further anchorcentral valve section 80 to the native atrioventricular valve.

For some embodiments, as described hereinabove, protrusions 84 are suchas to (a) prevent proximal migration of the central valve section intothe patient's atrium, while (b) allowing movement of the native leafletswith respect to the frame of the central valve section. For example, theprotrusions may have the aforementioned functionalities by havinglengths of less than 5 mm and/or by a total width of each set ofprotrusions corresponding to respective leaflets of the native valvebeing less than 5 mm. For example, the central valve section may includea single protrusion corresponding to each leaflet of the native valve,the width of each of the single protrusions being less than 1 mm. Thus,the central valve section may be stopped from proximally migrating intothe atrium, by the protrusions preventing the distal end of the centralvalve section from migrating further proximally than edges of nativeleaflets of the valve. Furthermore, the protrusions may allow movementof the native leaflets with respect to the frame of the central valvesection by not generally squeezing the native leaflets between theprotrusions and the frame of the central valve section. For someembodiments, by allowing movement of the native leaflets with respect tothe frame of the central valve section, sealing of the native leafletsagainst the outer surface of the frame of the central valve section isfacilitated, in accordance with the techniques described hereinbelowwith reference to FIG. 10.

Subsequent to the placement of the central valve section at the nativevalve, sheath 25, overtube 70, pushing elements 52 a and 52 b, guidemember 21, anchor base 302, and guidewire 306 are removed from thepatient's body, as shown in FIG. 7F, which shows the central valvesection in its deployed state. For some embodiments, in order to removeguide member 21 from the patient's body, guide member portions 21 a and21 b are decoupled from guide member tube 320. For example, the guidemember portions may be coupled to the guide member tube via threading,the guide member portions being decoupled from the guide member tube byunscrewing the guide member portions from the guide member tube.

Reference is now made to FIGS. 8A-C which are schematic illustrations ofa system 120 including an invertible spacer 140, in accordance with someembodiments of the present disclosure. Invertible spacer 140 isidentical to spacer 40 described herein, with the exception that thecylindrical skirt 142 of the spacer 140 is invertible, as is describedhereinbelow. Additionally, the method of advancing toward and implantingspacer 140 at annulus 11 is identical to the methods of advancing towardand implanting spacer 40 at annulus 11, as described hereinabove.

Spacer 140 includes a disc-shaped wall 144 (that is identical todisc-shaped wall 44 described hereinabove) and a cylindrical skirt 142.Cylindrical skirt 142 has a first end 150, a second end 152, and acylindrical body 153 disposed between first and second ends 150 and 152.Cylindrical skirt 142 is attached to disc-shaped wall 144 at first end150 of cylindrical skirt 142.

During and following implantation of spacer 140 at annulus 11, as shownin FIG. 8A, cylindrical skirt 142 is disposed above disc-shaped wall 144in a manner in which second end 152 and cylindrical body 153 aredisposed above disc-shaped wall 144 and within atrium 4. One or moreelongate guide members 146 a and 146 b are reversibly coupled tocylindrical skirt 142 in a vicinity of second end 152. Elongate guidemembers 146 a and 146 b facilitate (a) advancement of central valvesection 80 therealong and toward spacer 140, and (b) inversion ofcylindrical skirt 142 toward ventricle 6 when at least a portion ofcentral valve section 80 is deployed within ventricle 6 (as shown inFIG. 8B).

The configuration of spacer 140 as shown in FIG. 8A (i.e., theconfiguration in which cylindrical skirt 142 is disposed within atrium4) eliminates the obstruction of native valve 5 and of leaflets 12 and14 by any portion of spacer 140. In this manner, spacer 140 may beimplanted at valve 5 while valve 5 resumes its native function andleaflets 12 and 14 resume their natural function (as shown by thephantom drawing of leaflets 12 and 14 in FIG. 8A which indicates theirmovement). This atrially inverted configuration of spacer 140 reducesand even eliminates the amount of time the patient is undercardiopulmonary bypass. Only once central valve section 80 is deliveredand coupled to spacer 140 and cylindrical skirt 142 is therebyventricularly-inverted, native leaflets 12 and 14 are pushed aside (FIG.8B).

FIG. 8B shows the inversion of cylindrical skirt 142 by the partialpositioning and deployment of central valve section 80 within ventricle6. Elongate guide members 146 a and 146 b are reversibly coupled tocentral valve section 80 and extend within overtube 70. Following thefull deployment of central valve section 80 and the coupling of centralvalve section 80 to spacer 140, elongate guide members 146 a and 146 bare decoupled from central valve section 80 and from cylindrical skirt142. For example, a cutting tool may be used to decouple elongatemembers 146 a and 146 b from the spacer 140. Alternatively, elongatemembers 146 a and 146 b may be looped through the cylindrical skirt 142,such that both ends of each elongate member 146 a and 146 b remainoutside of the patient's body. The operating physician decoupleselongate members 146 a and 146 b from spacer 140 by releasing one end ofeach of elongate members 146 a and 146 b and pulling on the other end,until elongate members 146 a and 146 b are drawn from spacer 140 andremoved from within the body of the patient.

FIG. 80 shows central valve section 80 coupled to spacer 140. Centralvalve section 80 is identical to the central valve section describedhereinabove.

Reference is now made to FIGS. 9A-E, which are schematic illustrationsof the advancement of an invertible spacer 300 toward a nativeatrioventricular valve of a patient, and inversion of the spacer, inaccordance with some embodiments of the present disclosure. Spacer 300is used to anchor central valve section 80 to native valve 5 in agenerally similar manner to that described with reference to spacer 40.

During an exemplary procedure, anchor base 302 is advanced toward thevicinity of apex 304 of heart 2, via sheath 25, and is anchored to thevicinity of the apex, as shown in FIG. 8A. A guidewire 306 extendsproximally from the anchor base. A distal tensioning element 308 (e.g.,a plunger) is advanced over guidewire 306 into ventricle 6, and spacer300 is advanced out of the distal end of sheath 25, as shown in FIG. 9B.A first end 310 of spacer 300 (which at this stage is the distal end ofthe spacer), includes barbs 314 (shown in FIG. 9B), or other anchoringelements for anchoring the first end of the spacer to tissue of nativevalve 5. Spacer 300 is pushed distally such that the barbs are pushedinto the native valve tissue, thereby anchoring the first end of thespacer to the native valve, as shown in FIG. 9C. A plurality of wires309 pass from distal tensioning element 308 to a proximal tensioningelement 311 (shown in FIG. 9D), via a second end 312 of spacer 300(which at this stage is the proximal end of the spacer). For someembodiments, a sealing element 316 is disposed circumferentially arounda surface of the invertible spacer that is initially an inner surface ofthe invertible spacer (a shown in FIGS. 8A-D). For example, the sealingmaterial may be latex, dacron, or another suitable biocompatible sealingmaterial.

Subsequent to the anchoring of first end 310 of spacer 300 to nativevalve tissue (as shown in FIG. 90), distal tensioning element 308 isfurther advanced distally into ventricle 6, and proximal tensioningelement 311 is advanced toward the ventricle. As shown in the transitionfrom FIG. 9D-F, as the proximal tensioning element passes through thespacer, wires 309 cause spacer 300 to invert, by pulling second end 312of the spacer through first end 310 of the spacer. Subsequent to theinversion of the spacer, sealing material 316 is disposedcircumferentially around the outside of the spacer, thereby providing aseal at the interface between spacer 300 and native valve 5.

Reference is now made to FIGS. 9G-H, which are schematic illustrationsof the deployment of central valve section 80 and the coupling of thecentral valve section to invertible spacer 300, in accordance with someembodiments of the present disclosure.

The deployment of central valve section 80 is generally similar to thetechniques described hereinabove with reference to FIGS. 2H-J. Thecentral valve section is partially deployed in ventricle 6, via overtube70. Following the partial deployment of central valve section 80 inventricle 6, overtube 70 is pulled proximally (as shown in FIG. 8G) topull central valve section 80 proximally such that spacer 300 surroundsa proximal portion of central valve section 80, as shown in FIG. 8H.Central valve section 80 may be configured to expand such that centralvalve section 80 is held in place with respect to spacer 300responsively to radial forces acted upon spacer 300 by central valvesection 80.

As described hereinabove, for some embodiments, central valve section 80includes a plurality of distal protrusions 84. When central valvesection 80 is pulled proximally, protrusions 84 ensnare and engage thenative leaflets of the atrioventricular valve. By the ensnaring of thenative leaflets, protrusions 84 sandwich the native valve betweenprotrusions 84 and spacer 300. Such ensnaring helps further anchorcentral valve section 80 to the native atrioventricular valve.

For some embodiments, as described hereinabove, protrusions 84 are suchas to (a) prevent proximal migration of the central valve section intothe patient's atrium, while (b) allowing movement of the native leafletswith respect to the frame of the central valve section. For example, theprotrusions may have the aforementioned functionalities by havinglengths of less than 5 mm, and/or by a total width of each set ofprotrusions corresponding to respective leaflets of the native valvebeing less than 5 mm. For example, the central valve section may includea single protrusion corresponding to each leaflet of the native valve,the width of each of the single protrusions being less than 1 mm. Thus,the central valve section may be stopped from proximally migrating intothe atrium, by the protrusions preventing the distal end of the centralvalve section from migrating further proximally than edges of nativeleaflets of the valve. Furthermore, the protrusions may allow movementof the native leaflets with respect to the frame of the central valvesection by not generally squeezing the native leaflets between theprotrusions and the frame of the central valve section. For someembodiments, by allowing movement of the native leaflets with respect tothe frame of the central valve section, sealing of the native leafletsagainst the outer surface of the frame of the central valve section isfacilitated, in accordance with the techniques described hereinbelow hreference to FIG. 10.

Additionally, as shown in FIG. 9H, and as described hereinabove, centralvalve section 80 includes one or more coupling elements 81 (for example,a plurality of coupling elements, as shown) at the proximal end ofcentral valve section 80. Overtube 70, which facilitates the advancementof central valve section 80, is reversibly coupled to central valvesection 80, via coupling elements 81.

Subsequent to the coupling of central valve section 80 to spacer 300,overtube 70, distal and proximal tensioning elements 308 and 311, andwires 309 are removed from the patient's body, via sheath 25. In someembodiments, wires 309 are cut, in order to facilitate the removal ofthe wires from the patient's body. Guidewire 306 and anchor base 302 areremoved from the patient's body by detaching the anchor base from apex304, and withdrawing the anchor base and the guidewire, via sheath 25.

Reference is now made to FIG. 10, which is a schematic illustration ofcentral valve section 80, for placing inside atrioventricular valve 5 ofthe patient, in accordance with some embodiments of the presentdisclosure. The expandable frame 79 of the central valve section has adiameter d, and a corresponding cross-sectional area. Native annulus 11,which is in some embodiments saddle-shaped, defines an area A, as shown.For some embodiments, area A, which is defined by the native annulus ismeasured, e.g., using a measuring ring. A central valve section ischosen to be placed in the annulus, the cross-sectional area of thecentral valve section being less than 90% (e.g., less than 80%, or lessthan 60%) of area A. For some embodiments, diameter d of the centralvalve section is less than 25 mm, e.g., less than 20 mm, and/or morethan 15 mm, e.g., 15-25 mm. For some embodiments, placing a centralvalve section inside the native valve with the dimensions of the nativevalve annulus and the central valve section as described, facilitatessealing of the central valve section with respect to the native valve,by the native valve leaflets closing around the outer surface of thecentral valve section.

For some embodiments, a spacer 40 that includes disc-shaped wall 44(e.g., as shown in FIGS. 14A-C) is chosen to be placed at the annulus,the disc-shaped wall defining an inner cross-sectional area that is lessthan 90% (e.g., less than 80%, or less than 60%) of area A. Centralvalve section 80 is deployed at the native valve by coupling the centralvalve section to the spacer at the location, responsively to radialforces acted upon the spacer by the expandable frame, by facilitatingexpansion of the expandable frame, as described herein. Thecross-sectional area defined by the expandable frame of the centralvalve section, upon expansion of the expandable frame, is limited by thecross-sectional area defined by the disc-shaped wall of the spacer toless than 90% (e.g., less than 80%, or less than 60%) of area A. Forsome embodiments, placing a spacer at the annulus with the dimensions ofthe native valve annulus and spacer 40, as described, facilitatessealing of the central valve section with respect to the native valve,by the native valve leaflets closing around the outer surface of thecentral valve section.

In some embodiments, placing a central valve section inside the nativevalve with the dimensions of the native valve annulus, the central valvesection 80, and/or spacer 40 as described in the above paragraphs,facilitates sealing of the central valve section with respect to thenative valve. For some embodiments, the sealing is facilitated by thenative leaflets being pushed against, and closing against, the outersurface of the frame of the central valve section during systole, in asimilar manner to the manner in which native valve leaflets coapt duringsystole, in a healthy mitral valve. In some embodiments, as the diameterof the central valve section is increased, the length of the nativeleaflets that is pushed against the outer surface of the central valvesection during systole is increased, thereby enhancing the sealing ofthe native leaflets with respect to the frame of the central valvesection. However, beyond a given diameter, as the diameter of thecentral valve section is increased, the native valve leaflets are pushedapart at the commissures, thereby causing retrograde leakage of bloodthrough the commissures. Therefore, in accordance with some embodimentsof the present disclosure, central valve section 80, and/or spacer 40are chosen such that the cross-sectional area of the central valvesection when expanded inside the spacer is less than 90% (e.g., lessthan 80%, or less than 60%) of area A. Thus the spacer facilitatessealing of the central valve section with respect to the native valve,by the native valve leaflets closing around the outer surface of thecentral valve section, while not causing retrograde leakage of bloodthrough the commissures.

For some embodiments, in order to facilitate the sealing of the nativevalve around the outer surface of the central valve section, a materialis placed on the outer surface of the central valve section in order toprovide a sealing interface between the central valve section and thenative valve. For example, a smooth material that prevents tissue growth(e.g., polytetrafluoroethylene (PTFE), and/or pericardium) may be placedon the outer surface of the central valve section. Alternatively oradditionally, a material that facilitates tissue growth (such as dacron)may be placed on the outer surface of the central valve section, inorder to (a) act as a sealing interface between the native valve and thecentral valve section, and (b) facilitate tissue growth around thecentral valve section to facilitate anchoring and/or sealing of thecentral valve section.

Reference is now made to FIGS. 11A-D, which are schematic illustrationsof central valve section 80, in accordance with some embodiments of thepresent disclosure. For some embodiments, protrusions 84 are disposed onthe central valve section on portions 400 of the central valve sectionthat are placed adjacent to the anterior and posterior leaflets of thenative valve, and the central valve section does not include protrusionson portions 402 of the central valve section that are placed adjacent tothe commissures of the native valve.

FIGS. 11B-D show bottom views (i.e., views of the distal ends) ofrespective configurations of central valve section 80 and protrusions84. The protrusions converge from the proximal ends 404 of theprotrusion to the distal ends 406 of the protrusions. The protrusionsare configured such as to ensnare chordae tendineae, and to pull thechordae tendineae toward each other when the central valve section ispulled proximally, due to the convergence of the snares with respect toeach other. FIG. 11D shows the central valve section deployed at nativevalve 5. As shown, the protrusions ensnare chordae tendineae 102 of thepatient. The protrusions facilitate sealing and anchoring of the centralvalve section with respect to the native valve by pulling the chordaetendinae toward each other, as described. As described hereinabove, forsome embodiments the central valve section does not define protrusions84 on portions 402 that are placed next to the native commissures, e.g.,commissure 8, shown in FIG. 11D.

For some embodiments, as described hereinabove, protrusions 84 are suchas to (a) prevent proximal migration of the central valve section intothe patient's atrium, while (b) allowing movement of the native leafletswith respect to the frame of the central valve section. For example, theprotrusions may have the aforementioned functionalities by havinglengths of less than 5 mm, and/or by a total width of each set ofprotrusions corresponding to respective leaflets of the native valvebeing less than 5 mm. For example, the central valve section may includea single protrusion corresponding to each leaflet of the native valve,the width of each of the single protrusions being less than 1 mm. Thus,the central valve section may be stopped from proximally migrating intothe atrium, by the protrusions preventing the distal end of the centralvalve section from migrating further proximally than edges of nativeleaflets of the valve. Furthermore, the protrusions may allow movementof the native leaflets with respect to the frame of the central valvesection by not generally squeezing the native leaflets between theprotrusions and the frame of the central valve section. For someembodiments, by allowing movement of the native leaflets with respect tothe frame of the central valve section, sealing of the native leafletsagainst the outer surface of the frame of the central valve section isfacilitated, in accordance with the techniques described hereinabovewith reference to FIG. 10.

For some embodiments, a first set of protrusions 84 from the distal endof central valve section 80 are disposed within a first circumferentialarc with respect to a longitudinal axis of the central valve section, ona first side of the distal end of the central valve section, the firstside of the distal end being configured to be placed adjacent to theanterior leaflet of the native valve. A second set of protrusions aredisposed within a second circumferential arc with respect to alongitudinal axis of the central valve section, on a second side of thedistal end of the central valve section, the second side of the distalend being configured to be placed adjacent to the posterior leaflet ofthe native valve.

The first and second sets of protrusions are disposed so as to providefirst and second gaps therebetween at the distal end of the centralvalve section. In some embodiments, at least one of the gaps between thetwo sets of protrusions has a circumferential arc of at least 20 degrees(e.g., at least 60 degrees, or at least 100 degrees), and/or less than180 degrees (e.g., less than 140 degrees), e.g., 60-180 degrees, or100-140 degrees. Further in some embodiments, one or both of the firstand second circumferential arcs defines an angle of at least 25 degrees(e.g., at least 45 degrees), and/or less than 90 degrees (e.g., lessthan 75 degrees), e.g., 25-90 degrees, or 45-75 degrees.

Valve section guide members (e.g., guide members 21 a and 21 b, and/ordelivery lumen 27 a and 27 b, as described hereinabove) are delivered tocommissures of the native valve, and guide the central valve sectionsuch that the first and second circumferential arc are aligned withrespective leaflets of the native valve and such that the first andsecond gaps are aligned with respective commissures of the native valve.

Reference is now made to FIGS. 12A-C, which are schematic illustrationsof central valve section 80, the central valve section defining distalprotrusions 84 that are disposed sinusoidally around the circumferenceof the central valve section, in accordance with some embodiments of thepresent disclosure. For some embodiments the protrusions are shapedsinusoidally, in order to conform with the saddle-shape of native valveannulus 11, thereby facilitating the sandwiching of the native valveleaflets between the protrusions and spacer 40. As shown, the peaks ofthe sinusoid that is defined by the protrusions is disposed on portions402 that are placed next to the native commissures and the troughs ofthe sinusoid is placed on portions of the central valve section that areplaced in the vicinity of the centers of the anterior and posteriorleaflets of the native valve. As shown in FIG. 12C, for some embodimentsthe distal end of the central valve section defines a sinusoidal shape.

Reference is now made to FIGS. 13A-E, which are schematic illustrationsof respective configurations of expandable frame 79 of central valvesection 80, in accordance with some embodiments of the presentdisclosure. As described hereinabove, for some embodiments, centralvalve section 80 defines distal protrusions 84 that are configured tofacilitate sandwiching of the native valve leaflets between theprotrusions and spacer 40. For some embodiments, tips of the distalprotrusions are shaped so as to prevent the tips from piercing, and/orotherwise damaging, tissue of the native leaflets. For example, the tipsof the protrusions may be curved, as shown in FIG. 13A. Or, the distaltips of the protrusions may be shaped as balls, as shown in FIG. 13,and/or a different rounded shape. For some embodiments, the distal tipof each of the protrusions is joined to the distal tip of an adjacentprotrusion by an arch 410, as shown in FIGS. 130 and 13D.

For some embodiments, the protrusions are configured to bedistally-facing during the insertion of central valve section 80 intothe subject's left ventricle. For example, the central valve section maybe inserted through overtube 70 (shown in FIG. 7E, for example). Thecentral valve section is crimped during the insertion of the centralvalve section through the overtube, and the protrusions are constrainedin their distally-facing configurations by the overtube. The protrusionsare preshaped such that in the resting state of the protrusions, theprotrusions assume proximally-facing configurations, as shown in FIG.13D, for example. Thus, upon emerging from overtube 70, the protrusionsassume proximally-facing configurations. For some embodiments, when theprotrusions assume the proximally-facing configurations, the protrusionsare disposed at an angle theta (FIG. 13D) from expandable frame 79 ofmore than 40 degrees (e.g., more than 50 degrees), and/or less than 80degrees (e.g., less than 70 degrees).

In some embodiments, protrusions 84 are coupled to frame 79 of centralvalve section 80 at joints 412. For some embodiments, joints 412 arethinner than portions of the protrusions and of the frame surroundingthe joints, as shown in FIG. 13D. For some embodiments, the thinness ofthe joints with respect to the surrounding portions facilitates thecrimping of the protrusions into distally-facing configuration duringthe insertion of the central valve section into the heart.

For some embodiments, barbs 416 extend from a proximal portion ofexpandable frame 79 of central valve section 80, as shown in FIG. 13E,For example, the barbs may be configured to anchor the central valvesection to the native valve by piercing tissue of the native valve.Alternatively or additionally, the barbs may be configured to anchor thecentral valve section to the spacer 40, by becoming coupled to portionsof the spacer. For some embodiments the barbs protrude from thetop-central corner of respective cells of expandable frame 79. In someembodiments, when the central valve section is crimped, the barbs fitwithin gaps of respective cells of the expandable frame, and do notsubstantially increase the crimping profile of the central valvesection, relative to a generally similar central valve section that doesnot include barbs.

For some embodiments, the barbs are not generally used for couplingcentral valve section 80 to spacer 40. Rather, the central valve sectionis coupled to the spacer by virtue of radial expansion of the centralvalve section against disc-shaped wall 44 of the spacer. Barbs 416 areused to prevent central valve section from migrating distally into thepatient's left ventricle, and/or to prevent spacer 40 from migratingproximally into the subject's left atrium.

For some embodiments (not shown), barbs protrude from coupling elements81 of central valve section 80, the barbs being generally similar inshape and function to that described with reference to barbs 416. Forsome embodiments (not shown), radially-inwardly facing barbs 45 protrudefrom disc-shaped wall 44 of spacer 40, as shown in FIG. 14D. Asdescribed with reference to barbs 416, the barbs that protrude fromdisc-shaped wall 44 may facilitate coupling of the central valve sectionto the spacer. Alternatively or additionally, the barbs that protrudefrom disc-shaped wall 44 are used to prevent central valve section frommigrating distally into the patient's left ventricle, and/or to preventspacer 40 from migrating proximally into the subject's left atrium.

For some embodiments, a proximal end of expandable frame 79 of centralvalve section 80 defines a larger cross-section area than more distalportions of the expandable frame. For example, the expandable frame mayhave a frustoconical shape, the walls of the expandable frame divergingfrom a distal end of the frame to a proximal end of the frame.Alternatively, the expandable frame may have a trumpet shape (i.e., theframe may be generally tubular, with a dilated proximal end). For someembodiments, the larger cross-sectional area of the proximal end of theframe prevents the central valve section from migrating distally intothe patient's left ventricle, and/or prevents spacer 40 from migratingproximally into the subject's left atrium.

Reference is now made to FIGS. 14A-D, which are schematic illustrationsof respective configurations of spacer 40, in accordance with someembodiments of the present disclosure. As described hereinabove, forsome embodiments, the spacer includes a proximal disc-shaped wall 44 anda distal cylindrical skirt 42 (e.g., as shown in FIG. 2D).Alternatively, the spacer does not include a distal cylindrical element.For example, the spacer may only include disc-shaped wall 44. Asdescribed hereinabove, disc-shaped wall 44 is configured to be placedaround native annulus 11 of the native valve, and to extend at leastpartially into atrium 4 such that disc-shaped wall 44 rests against thenative annulus. Disc-shaped wall 44 is in some embodiments too large topass through the annulus, and may, for example, have an outer diameterof between 30 and 60 mm.

FIGS. 14A-D show disc-shaped wall 44 of spacer 40 in respectiveconfigurations, in accordance with some embodiments of the presentdisclosure. For some embodiments, the disc-shaped wall is D-shaped, asshown in FIG. 14A. Alternatively or additionally, the disc-shaped wallhas a generally round shape, as shown in FIGS. 14B-C. For someembodiments the disc-shaped wall is asymmetrical. For example, FIG. 14Bshows a generally rounded disc-shaped wall that is wider on a first side420 of the element than on a second side 422 of the element. In someembodiments, the wider side of the disc-shaped wall is placed on theanterior side of the native annulus. In accordance with someembodiments, the disc-shaped wall is symmetrical, asymmetrical, oval,round, defines a hole that is centered with respect to the disc-shapedwall, and/or defines a hole that is off-center with respect to thedisc-shaped wall. For some embodiments, the stiffness of the disc-shapedwall varies around the circumference of the disc-shaped wall.

For some embodiments, disc-shaped wall 44 is asymmetrical, as shown inFIG. 14B. In some embodiments, the asymmetry of the disc-shaped wall issuch that the center of the hole defined by the disc-shaped wall isdisposed asymmetrically (i.e., off-center) with respect to the center ofthe disc-shaped wall, as defined by the outer perimeter of thedisc-shaped wall. For some embodiments, the asymmetric disposition ofthe center of the hole defined by the disc-shaped wall is such that whenthe central valve section is placed inside the disc-shaped wall, thelongitudinal axis of the central valve section is disposedasymmetrically (i.e., off-center) with respect to the center of thedisc-shaped wall, as defined by the outer perimeter of the disc-shapedwall. In some embodiments, the disc-shaped wall is shaped such that,when the disc-shaped wall is placed on the patient's mitral annulus, andthe central valve section is expanded inside the disc-shaped wall, thelongitudinal axis of the central valve section is disposed in thevicinity of the location at which the patient's native leaflets coapt(this location being off-center with respect to the patient's nativemitral annulus).

For some embodiments (not shown), radially-inwardly facing barbs 45protrude from disc-shaped wall 44 of spacer 40, as shown in FIG. 14D. Asdescribed with reference to barbs 416 shown protruding from centralvalve section 80 in FIG. 13E, the barbs that protrude from disc-shapedwall 44 may facilitate coupling of the central valve section to thespacer. Alternatively or additionally, the barbs that protrude fromdisc-shaped wall 44 are used to prevent central valve section frommigrating distally into the patient's left ventricle, and/or to preventspacer 40 from migrating proximally into the subject's left atrium. Forsome embodiments, some or all of barbs 102 are curved. In someembodiments, the curved barbs curve away from the plane of disc-shapedwall 44, such that, when implanted, barbs 102 point into the patient'satrium.

In some embodiments, the disc-shaped wall includes support stent 48, thestent being covered at least in part with covering 49, e.g., fabric. Insome embodiments, the upper surface of disc-shaped wall 44 is coveredwith fabric, for example, in order to provide a generally smooth surfacefor coming into contact with the patient's blood flow. Further in someembodiments, the lower surface of the disc-shaped wall (i.e., the sideof the disc-shaped wall that is placed in contact with the nativeannulus) is not covered with fabric, for example, in order to reduce acrimped volume (or cross-sectional area) of the disc-shaped wall,relative to the volume of the disc-shaped wall if the lower surface ofthe disc-shaped wall were covered in fabric. In some embodiments, athickness of the fabric layer is less than 0.2 mm, e.g., less than 0.1mm, or less than 0.05 mm.

For some embodiments, the side of the disc-shaped wall that is placed incontact with the native annulus is covered with the fabric, the fabricbeing configured to facilitate coupling of the disc-shaped wall to thenative annulus, by facilitating fibrosis at the interface between thedisc-shaped wall and the native annulus. For some embodiments, the uppersurface of the disc-shaped wall is not covered with fabric. For example,the upper surface may not be covered in fabric in order to reduce acrimped volume (or cross-sectional area) of the disc-shaped wall,relative to the volume of the disc-shaped wall if the upper surface ofthe disc-shaped wall were covered in fabric.

For some embodiments, disc-shaped wall 44 is not covered with fabric,and/or is not configured to form a seal against frame 79 of centralvalve section 80. For some embodiments, the disc-shaped wall isconfigured to allow leakage of blood between the disc-shaped wall andframe 79 of central valve section 80. For example, the disc-shaped wallmay be configured to allow leakage of blood through the interfacebetween the disc-shaped wall and the frame of the central valve section,in order to accommodate a flow of blood between the patient's atrium andthe patient's ventricle that is greater than can be accommodated byblood flowing through the leaflets of the central valve section.

Reference is now made to FIGS. 15A-E, which are schematic illustrationsof respective steps of a procedure for deploying a central valvesection, in accordance with some embodiments of the present disclosure.As described hereinabove and hereinbelow (for example, with reference toFIGS. 2A-K, 7A-F, 8A-C, 9A-H, and 16A-G), for some procedures, spacer 40is placed on the valve annulus and, subsequently, central valve section80 is inserted into the subject's left ventricle through the spacer.Alternatively, any of the procedures described herein (for example,procedures described with reference to FIGS. 2A-K, 7A-F, 8A-C, 9A-H, and16A-G) may be performed by first placing the central valve sectioninside the subject's left ventricle, and, subsequently, deploying thespacer at the annulus. For example, FIGS. 15A-E show a procedure inwhich the central valve section is placed inside the subject's leftventricle, and, subsequently, the spacer is deployed at the annulus.

As shown in FIG. 15A, for some embodiments, central valve section 80 isplaced in the subject's ventricle, before spacer 40 is placed at thenative valve. The central valve section is in some embodiments placed inthe left ventricle in an undeployed state, via overtube 70.Subsequently, the spacer is placed at the native valve using pushingelements, as shown in FIG. 15B. For some embodiments, three pushingelements 52 a, 52 b, and 52 c are used to push the spacer against thenative valve, as shown in FIG. 15B.

Subsequent to the placement of spacer 40 at the native valve, centralvalve section 80 is coupled to spacer 40. For some embodiments, pushingelements 52 a, 52 b, and 52 c continue to push the spacer against thenative valve, during the coupling of the central valve section to thespacer. FIG. 15C shows central valve section having been partiallydeployed in the ventricle.

Following the partial deployment of central valve section 80 inventricle 6, overtube 70 is pulled proximally to pull central valvesection 80 proximally such that disc-shaped wall 44 of spacer 40surrounds a proximal portion of central valve section 80, as shown inFIG. 15D. Central valve section 80 may be configured to expand such thatcentral valve section 80 is held in place with respect to spacer 40responsively to radial forces acted upon spacer 40 by central valvesection 80. During the pulling back of overtube 70, pushing elements 52a, 52 b, and 52 c push spacer 40 against the central valve section,thereby providing a counter force against which overtube 70 is pulledback. For some embodiments, the pushing of the spacer against thecommissures is such that it is not necessary to use anchors foranchoring the spacer to the native valve during the coupling of thecentral valve section to the spacer. Alternatively, in addition to thepushing elements providing a counter force against which the centralvalve section is pulled, anchors are used to anchor the spacer to thenative valve during the coupling of the central valve section to thespacer.

As described hereinabove, central valve section 80 includes a pluralityof distal protrusions 84. When central valve section 80 is pulledproximally, as described hereinabove, protrusions 84 ensnare and engagethe native leaflets of the atrioventricular valve. By the ensnaring ofthe native leaflets, protrusions 84 sandwich the native valve betweenprotrusions 84 and spacer 40. Such ensnaring helps further anchorcentral valve section 80 to the native atrioventricular valve.

It is noted with reference to FIG. 15D that, in some embodiments,disc-shaped wall 44 of spacer 40 defines an inner cross-sectional areathereof. As described hereinabove, central valve section 80 includesexpandable frame 79, and prosthetic leaflets 82. The expandable frame ofthe central valve section is configured such that when the frame is in anon-constrained state thereof, the cross-sectional area of the frame,along at least a given portion L (shown in FIG. 15D) of the length ofthe frame, is greater than the inner cross-sectional area defined by thedisc-shaped wall of the spacer. In some embodiments, during a centralvalve section deployment procedure, a location anywhere along portion Lat which to couple the expandable central valve section to the spacer isselected. In response thereto, the location along the portion of theexpandable frame is aligned with the disc-shaped wall of the spacer. Theexpandable central valve section is then coupled to the spacer at thelocation, responsively to radial forces acted upon the spacer by theexpandable frame, by facilitating expansion of the expandable frame,when the location along the portion is aligned with the disc-shaped wallof the spacer.

As described hereinabove, for some embodiments, expandable frame 79 ofcentral valve section 80 has a frustoconical shape. For someembodiments, the central valve section is coupled to spacer 40responsively to radial forces acted upon the spacer by the expandableframe, when a given location along portion L is aligned with disc-shapedwall 44 of the spacer. For some embodiments, the portion immediatelyproximal to the given location along portion L has a greatercross-sectional area than the frame at the given location, due to thefrustoconical shape of the expandable frame. In some embodiments, thegreater cross-sectional area of the portion immediately proximal to thegiven location along portion L relative to the cross-sectional area ofthe frame at the given location, reduces distal migration of the centralvalve section toward the subject's left ventricle.

For some embodiments, the location along portion L at which to couplecentral valve section 80 to spacer 40 is selected, based upon a distanceD between protrusions 84 and disc-shaped wall 44 that would result fromcoupling the central valve section to the disc-shaped wall at thatlocation. For example, the location along portion L at which to couplecentral valve section 80 to spacer 40 may be selected, such thatdistance D is such as to anchor the central valve section to thepatient's native valve by squeezing the patient's native valve leafletsbetween the protrusions and the disc-shaped wall, and/or by ensnaringthe patient's chordae tendinae between the protrusions and thedisc-shaped wall. Alternatively or additionally, the location alongportion L at which to couple central valve section 80 to spacer 40 maybe selected, such that distance D is such that protrusions 84 (a)prevent proximal migration of the central valve section into thepatient's atrium, while (b) allowing movement of the native leafletswith respect to the frame of the central valve section. In someembodiments, the location along portion L is selected such that distanceis such that the central valve section may be stopped from proximallymigrating into the atrium, by the protrusions preventing the distal endof the central valve section from migrating further proximally thanedges of native leaflets of the valve, while the protrusions allowmovement of the native leaflets with respect to the frame of the centralvalve section by not generally squeezing the native leaflets between theprotrusions and the frame of the central valve section. For someembodiments, by allowing movement of the native leaflets with respect tothe frame of the central valve section sealing of the native leafletsagainst the outer surface of the frame of the central valve section isfacilitated, in accordance with the techniques described hereinabovewith reference to FIG. 10.

Subsequent to the placement of the central valve section at the nativevalve, overtube 70, and pushing elements 52 a, 52 b, and 52 c areremoved from the patient's body, as shown in FIG. 15E, which shows thecentral valve section in its deployed state.

Reference is now made to FIGS. 16A-G, which are schematic illustrationsof respective steps of an alternative procedure for deploying centralvalve section 80, in accordance with some embodiments of the presentdisclosure. As described hereinabove, with reference to FIGS. 7A-F, forsome embodiments, a looped guide member 21 is looped through commissures8 and 10 in a manner in which the guide member defines a looped portionbetween commissures 8 and 10. For some embodiments, the looped guidemember has steering functionality. The steering functionality of thelooped guide member is used to guide the guide member to thecommissures, and/or to guide other portions of the apparatus to thenative valve and/or to ventricle 6. The looped guide member is in someembodiments advanced toward ventricle 6 over guidewire 306, e.g., asdescribed hereinabove with reference to FIG. 7A.

In some embodiments, as shown in FIG. 16A, portions 21 a and 21 b of thelooped guide member are independently manipulable. The portions of thelooped guide member are manipulated (e.g., expanded and contracted) soas to guide the looped guide member to the subject's native valve, bypushing against inner surfaces of the subject's heart, as shown in FIG.16A.

FIG. 16B shows the looped guide member looped through commissures 8 and10 of the subject's native valve. When the looped guide member isdisposed at the native valve, the guide member is used to guide and toanchor spacer 40, as described hereinbelow.

As shown in FIG. 160, for some embodiments, looped guide member 21 iscoupled to spacer 40 via coupling wires 500 and coupling mechanisms 502.For example, as shown, the coupling mechanism may include an anchor. Asuture 504, or a different looped element, protrudes from the bottomsurface of disc-shaped wall 44 of spacer 40 and is anchored by theanchor. Thus, when looped guide member 21 is pushed distally intoventricle 6, the spacer is pulled against the annulus of the nativevalve by coupling wires 500 pulling on the spacer.

In some embodiments, coupling mechanisms 502, which are used to couplelooped guide member 21 to spacer 40 are detachable coupling mechanisms.For example, as shown, the coupling mechanism may include an anchor thatdefines an opening 506 through which suture 504 is inserted. The openingis closed by a closing member 508, such as a rod, or a wire. In order todetach the guide member from the spacer, closing member 508 is opened(e.g., by being pulled proximally) such that suture 504 is releasedthrough opening 506.

Subsequent to the placement of spacer 40 at the native valve, centralvalve section 80 is placed in ventricle 6, by advancing overtube 70 intothe ventricle, as shown in FIG. 16D. FIG. 16E shows central valvesection having been partially deployed in the ventricle. Following thepartial deployment of central valve section 80 in ventricle 6, overtube70 is pulled proximally to pull central valve section 80 proximally suchthat disc-shaped wall 44 of spacer 40 surrounds a proximal portion ofcentral valve section 80, as shown in FIGS. 16E-F. Central valve section80 may be configured to expand such that central valve section 80 isheld in place with respect to spacer 40 responsively to radial forcesacted upon spacer 40 by central valve section 80.

During the pulling back of overtube 70, looped guide member 21 is pusheddistally, thereby pulling spacer 40 against the native annulus andproviding a counter force against which overtube 70 is pulled back. Forsome embodiments, pulling of the spacer against the native annulus issuch that it is not necessary to use anchors for anchoring the spacer tothe native valve during the coupling of the central valve section to thespacer. Alternatively, in addition to the pulling of the spacer againstthe native annulus providing a counter force against which the centralvalve section is pulled, anchors are used to anchor the spacer to thenative valve during the coupling of the central valve section to thecentral valve section.

FIG. 16G shows central valve section 80 and spacer 40 coupled to thenative valve. At this stage, coupling mechanism 502 is in someembodiments detached from the spacer. For example, as shown, closingmember 508 is pulled, such that opening 506 is opened, and suture 504 isreleased through the opening. Subsequently, looped guide member 21, andovertube 70 are removed from the subject's body, as shown in FIG. 16H,which shows the central valve section in its deployed state.

As described with reference to FIGS. 16A-H, for some embodiments,central valve section 80 is coupled to a native valve, by (a) placingspacer 40 on an atrial side of the native annulus, (b) placing thecentral valve section inside the ventricle, and then, simultaneously,(c) pulling the central valve section toward the atrium, and pulling thespacer toward the ventricle.

Reference is now made to FIGS. 17A-C, which are schematic illustrationsof leaflets 82 of central valve section 80, in accordance with someembodiments of the present disclosure. FIG. 17A shows the leafletsbefore the leaflets are sutured to expandable frame 79 of the centralvalve section. As shown, in this state, the leaflets have a diameter D1,and the leaflets are not fully closed. FIG. 17B shows the leaflets whenthe leaflets have been sutured to expandable frame 79 of the centralvalve section. The expandable frame constrains the leaflets, such thatthe leaflets define a diameter D2, which is smaller than diameter D1,thereby closing the leaflets. FIG. 17C shows the leaflets subsequent tothe deployment of central valve section 80 inside spacer 40, the spacerconstraining the expansion of the central valve section. Due to thespacer constraining the central valve section, the valve leaflets areconstrained so as define a diameter D3, which is smaller than diameterD2.

In some embodiments, valve leaflets 82 are selected to be used incentral valve section 80, the leaflets being sized such that both atdiameter D2 (when the leaflets are constrained by expandable frame 79but are not constrained by spacer 40) and at diameter D3 (when theleaflets are constrained by both expandable frame 79 and spacer 40), thevalve leaflets fully coapt.

Reference is now made to FIGS. 18A-B which are schematic illustrationsof a system 220 including a spacer 240 including a disc-shaped wall 244and a cylindrical skirt 242 and one or more (e.g., a plurality, asshown, of) tissue anchor bases 230, in accordance with some embodimentsof the present disclosure. Disc-shaped wall 244 has an upper surface 241and a lower surface 243. Tissue anchor bases 230 are coupled to lowersurface 234 of the disc-shaped wall. Tissue anchor bases 230 are shapedso as to define a pointed distal tip 234 and one or more (e.g., three,as shown) radially-expandable leaves 232. Leaves 232 include a flexiblemetal, e.g., nitinol or stainless steel, and have a tendency to expandradially. Tissue anchor bases 230 facilitate coupling of spacer 240 toannulus 11 of native valve 5, such as the mitral valve or the tricuspidvalve. Tissue anchor bases 230 are in some embodiments distributedapproximately evenly around lower surface 243 of disc-shaped wall 244.For some embodiments, one or more tissue anchor bases 230 are disposedat a location of disc-shaped wall that is configured to be positionedadjacently to commissures 8 and 10 of valve 5.

Reference is now made to FIGS. 19A-D which are schematic illustrationsof spacer 240 being implanted at valve 5 and the subsequent coupling ofcentral valve section 80 to spacer 240. Spacer 240 is advanced towardnative valve 5 by pushing elements 52 a and 52 b, as describedhereinabove with respect to spacer 40 with reference to FIGS. 2D-F. Inresponse to the pushing force to spacer 240 by pushing elements 52 a and52 b, tissue anchor bases 230 are pushed into tissue of annulus 11 ofvalve 5. The pushing force by elements 52 a and 52 b is sufficient toimplant each one of the plurality of tissue anchor bases that aredistributed around lower surface 243 of disc-shaped wall 244.

FIG. 19A shows initial penetration of tissue of annulus 11 by pointeddistal tip 234 of anchor base 230. In FIG. 19B, the initial force of thetissue on leaves 232 pushes inwardly leaves 232. Finally, in FIG. 19C,leaves 232 expand within tissue of annulus 11 to assume a flower shapeand a larger surface area to restrict proximal motion of anchor base 230and thereby anchor spacer 240 in tissue of annulus 11. As shown in FIGS.19A-C, the cylindrical element of spacer 240 pushes aside nativeleaflets 12 and 14 of valve 5.

In FIG. 19D, central valve section 80 is coupled to spacer 240, in amanner as described hereinabove.

It is noted that, in general, central valve section 80 isself-expandable. When the central valve section is deployed (i.e., whenthe central valve section self-expands) inside the subject's heart, theexpansion of the central valve section is in some embodimentsconstrained by spacer 40. Further in some embodiments, the expansion ofthe central valve section is not constrained by the native annulus.

For some embodiments, by constraining the expansion of the central valvesection with the spacer, the deployed cross-sectional area of thecentral valve section may be fixed at a given area, by using a spacerthat defines a hole having the given cross-sectional area. As describedhereinabove with reference to FIG. 10, for some embodiments, the areadefined by the native annulus is measured, and the cross-sectional areaof the central valve section that is to be deployed in the valve isselected based upon the measured area of the native annulus.Alternatively or additionally, spacer 40 is selected based upon themeasured area of the native annulus.

For example, a spacer may be selected such that the spacer constrainsthe expansion of the central valve section, when the cross-sectionalarea of the central valve section is less than 90% (e.g., less than 80%,or less than 60%) of the area defined by the native annulus. Asdescribed hereinabove, for some embodiments, placing a central valvesection inside the native valve with the dimensions of the native valveannulus and the central valve section being as described, facilitatessealing of the central valve section with respect to the native valve,by the native valve leaflets closing around the outer surface of thecentral valve section.

For some embodiments, the expansion of central valve section 80 againstspacer 40 couples the central valve section to the spacer, and/orcouples the central valve section and the spacer to the native mitralvalve. In some embodiments, the expansion of the central valve sectionagainst the spacer couples the central valve section to the spacer, andsandwiching of the native valve leaflets between protrusions from thedistal end of the central valve section and the spacer couples thecentral valve section and the spacer to the native valve.

Reference is now made to FIGS. 1A-D, 2A-K, 3A-D, 4A-C, 5A-D, 6A-B, 7A-F,8A-C, 9A-H, 10, 11A-D, and 12A-C. It is to be noted that spacer 40 maybe invertible as described hereinabove with respect to spacer 140 andspacer 300, with reference to FIGS. 8A-C, and 9A-H. It is to be furthernoted that spacer 140 and spacer 300 may be used in conjunction with oneor more of the elements for facilitating sealing of the native valvewith respect to a spacer or a central valve section that is describedwith reference to FIGS. 3A-D, 4A-C, 5A-D, and 6A-B. For example, spacer140 and spacer 300 may be used with sealing balloon 90, commissuralanchors 100 a and 100 b, grasping elements 106 a and 106 b, and/orsealing material 110. It is still further noted that spacer 140 andspacer 300 may be implanted using a guide member that defines a loopedportion between commissures 8 and 10, as described with reference toFIGS. 7A-F. It is further noted that any of the embodiments describedherein can be used in conjunction with central valve sections havingconfigurations as described with reference to FIGS. 10-12C.

The systems described herein are advanced toward valve 5 in atranscatheter procedure, as shown. It is to be noted, however, that thesystems described herein may be advanced using any suitable procedure,e.g., minimally-invasively (e.g., via a transeptal, a transatrial, atransapical, and/or a transaortic approach), or using an open-heartprocedure. It is to be further noted that spacers and prosthetic valvesherein may be used to replace native mitral valves or native tricuspidvalves.

Reference is now made to FIGS. 20A-B, which are schematic illustrationsof spacer 40 and central valve section 80 coupled respectively to atricuspid valve, and to an aortic valve, in accordance with someembodiments of the present disclosure. For some embodiments, spacer 40and central valve section 80 are deployed at a tricuspid valve and/or atan aortic valve using generally similar techniques to those describedherein with reference to the deployment of the spacer and the centralvalve section at the mitral valve, mutatis mutandis.

It will be appreciated by persons skilled in the art that the presentdisclosure is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present disclosureincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

The invention claimed is:
 1. A prosthetic heart valve, comprising: anannular spacer configured for deployment within a native heart valve,the annular spacer comprising: a cylindrical skirt having an upstreamend and a downstream end opposite from the upstream end, wherein aspacer opening extends through the cylindrical skirt between theupstream and downstream ends, and a disc-shaped wall arranged about theupstream end of the cylindrical skirt, the disc-shaped wall beingconfigured to obstruct blood flow, wherein the disc-shaped wallcomprises: a support stent having a plurality of struts, and at leastone opening configured to slide along a delivery mechanism, wherein afirst portion of the support stent situated around the at least oneopening has a different strut arrangement than a second portion of thesupport stent; and a central valve section having a central lumenconfigured to support a valve prosthesis therein, wherein the centralvalve section is configured for disposal within the spacer opening ofthe annular spacer and includes at least one anchoring protrusionconfigured to extend radially outward from a downstream end of thecentral valve section, wherein the central valve section is configuredfor deployment into the heart separately from the annular spacer, andwherein the at least one anchoring protrusion of the central valvesection is configured to extend through the downstream end of the spaceropening to prevent the central valve section from moving axiallyrelative to the annular spacer.
 2. The prosthetic heart valve of claim1, wherein the annular spacer is configured for engaging with an annulusof the native heart valve, and wherein the spacer opening is sized to besmaller than the annulus of the native heart valve.
 3. The prostheticheart valve of claim 1, wherein the central valve section is configuredfor implantation after implantation of the annular spacer.
 4. Theprosthetic heart valve of claim 1, wherein the annular spacer isconfigured to secure the central valve section relative to an annulus ofthe native heart valve.
 5. The prosthetic heart valve of claim 1,wherein the cylindrical skirt is configured to extend at least partiallyinto a ventricle of the heart, and wherein the disc-shaped wall isconfigured to contact an atrial side of the native heart valve.
 6. Theprosthetic heart valve of claim 1, wherein an outer diameter of thedisc-shaped wall is configured to be larger than an outer diameter of anupstream end of the central valve section.
 7. The prosthetic heart valveof claim 1, wherein the cylindrical skirt comprises: a second supportstent having a second plurality of struts; and a covering that covers atleast a portion of the second support stent along the downstream end ofthe cylindrical skirt.
 8. The prosthetic heart valve of claim 1, whereinthe central valve section includes: a flexible wire frame having asecond plurality of struts; and a plurality of anchoring protrusions,wherein each anchoring protrusion includes: a proximal end secured to atleast one strut of the flexible wire frame, and a distal end oppositefrom the proximal end.
 9. The prosthetic heart valve of claim 8, whereinthe anchoring protrusions are configured such that when the centralvalve section is disposed within the spacer opening of the annularspacer, a circumference defined by the distal ends of the anchoringprotrusions has a larger diameter than an outer diameter of thedownstream end of the cylindrical skirt.
 10. The prosthetic heart valveof claim 8, wherein the distal ends of the anchoring protrusions areconfigured to be the radially-outermost portions of the central valvesection, relative to a center of the central valve section.
 11. Theprosthetic heart valve of claim 1, wherein the at least one anchoringprotrusion is configured to extend radially outward beyond an outerdiameter of the downstream end of the cylindrical skirt when the centralvalve section is disposed within the spacer opening of the annularspacer.
 12. The prosthetic heart valve of claim 1, wherein the centralvalve section has a greater axial length than the annular spacer.
 13. Aprosthetic heart valve, comprising: an annular spacer configured fordeployment within a native heart valve, the annular spacer comprising: acylindrical skirt having an upstream end and a downstream end oppositefrom the upstream end, wherein a spacer opening extends through thecylindrical skirt between the upstream and downstream ends, and adisc-shaped wall arranged about the upstream end of the cylindricalskirt, wherein the disc-shaped wall is configured to obstruct bloodflow; a central valve section having a central lumen configured tosupport a valve prosthesis therein, wherein the central valve section isconfigured for disposal within the spacer opening of the annular spacerand includes at least one anchoring protrusion configured to extendradially outward from a downstream end of the central valve section; andat least one tissue anchor configured to extend through an opening ofthe disc-shaped wall to secure the disc-shaped wall to tissue of thenative heart valve, wherein the central valve section is configured fordeployment into the heart separately from the annular spacer, whereinthe at least one anchoring protrusion of the central valve section isconfigured to extend through the downstream end of the spacer opening toprevent the central valve section from moving axially relative to theannular spacer, and wherein the at least one tissue anchor is configuredfor deployment into the heart separately from the annular spacer andincludes a plurality of leaves configured to splay outward uponimplantation of the at least one tissue anchor.
 14. The prosthetic heartvalve of claim 13, wherein the at least one tissue anchor is configuredto engage ventricular tissue of the native heart valve.
 15. Theprosthetic heart valve of claim 13, wherein the at least one tissueanchor is configured to be secured to the disc-shaped wall via amale-female locking arrangement.
 16. A prosthetic heart valve,comprising: an annular spacer configured for deployment within a nativeheart valve, the annular spacer comprising: a cylindrical skirt havingan upstream end and a downstream end opposite from the upstream end,wherein a spacer opening extends through the cylindrical skirt betweenthe upstream and downstream ends, and a disc-shaped wall arranged aboutthe upstream end of the cylindrical skirt, wherein the disc-shaped wallis configured to obstruct blood flow; and a central valve section havinga central lumen configured to support a valve prosthesis therein,wherein the central valve section is configured for disposal within thespacer opening of the annular spacer and includes at least one anchoringprotrusion configured to extend radially outward from a downstream endof the central valve section, wherein the central valve section isconfigured for deployment into the heart separately from the annularspacer, wherein the at least one anchoring protrusion of the centralvalve section is configured to extend through the downstream end of thespacer opening to prevent the central valve section from moving axiallyrelative to the annular spacer, and wherein the cylindrical skirt isconfigured to be inverted such that a first end of the cylindrical skirtis situated upstream of the disc-shaped wall after deployment of theannular spacer within the native heart valve, the first end of thecylindrical skirt being the downstream end of the cylindrical skirt whenthe cylindrical skirt is in a non-inverted configuration.
 17. Theprosthetic heart valve of claim 16, wherein the central valve section isconfigured to reposition the first end of the inverted cylindrical skirtsuch that the cylindrical skirt is moved into the non-invertedconfiguration.
 18. The prosthetic heart valve of claim 16, configuredsuch that native leaflets of the heart are not obstructed by theprosthetic heart valve until the central valve section is implanted andthe cylindrical skirt is moved into the non-inverted configuration. 19.A prosthetic heart valve, comprising: an annular spacer configured fordeployment within a native heart valve, the annular spacer comprising: acylindrical skirt having an upstream end and a downstream end oppositefrom the upstream end, wherein a spacer opening extends through thecylindrical skirt between the upstream and downstream ends, and adisc-shaped wall arranged about the upstream end of the cylindricalskirt, wherein the disc-shaped wall is configured to obstruct bloodflow; and a central valve section having a central lumen configured tosupport a valve prosthesis therein, wherein the central valve section isconfigured for disposal within the spacer opening of the annular spacerand includes at least one anchoring protrusion configured to extendradially outward from a downstream end of the central valve section,wherein the central valve section is configured for deployment into theheart separately from the annular spacer, wherein the at least oneanchoring protrusion of the central valve section is configured toextend through the downstream end of the spacer opening to prevent thecentral valve section from moving axially relative to the annularspacer, wherein the at least one anchoring protrusion is configured toextend radially outward beyond an outer diameter of the downstream endof the cylindrical skirt when the central valve section is disposedwithin the spacer opening of the annular spacer, and wherein the atleast one anchoring protrusion is configured to engage native leafletsof the heart and to compress the native leaflets of the heart againstthe annular spacer.